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Slow growing cancer. I do believe the second word supersedes the first. --- Slow GROWING -----Great term but not so great in reality. The Ovarian cancer I spoke of some time back was termed as "slow growing" The 1 year PET scan came back with no change...But recently found that the cancer that was left on the colon is growing and constricting the colon. Gotta crank up the chemo machine again.
Sure would have made a difference to catch this cancer in (stage I) It was found somewhere between III and IV.
International Peer Reviewed Scientific Journal Publishes BioCurex Article Showing That a Combination of its Cancer Marker RECAF and CA125 Can be Used for Ovarian Cancer Screening
Reviewer Describes Results as Impressive
RICHMOND, British Columbia, June 8, 2011 (GLOBE NEWSWIRE) -- BioCurex Inc. (OTCBB:BOCX) today announced the publication of the article entitled: "Combination of CA125 and RECAF biomarkers for early detection of ovarian cancer" in a peer reviewed scientific journal specialized in cancer markers.
Ovarian cancer is called the silent killer because most patients have no symptoms until the tumor becomes very large and it has already spread. The majority of patients are diagnosed with advanced disease (stages III/IV), in which only 20% or less can be cured, placing ovarian cancer as the fourth leading cause of cancer death in women.
On the other hand, when detected in early stages (I and II), cancer of the ovary can be cured in 90% of the cases. Thus, developing screening tools for early detection of ovarian cancer is crucial to reduce its mortality rate. The major problem in developing these tools is the presence of false positives which can supersede, many times in number, the amount of cancers detected. Sorting out those false positives is very expensive and therefore a good screening tool must not only detect as many early cancers as possible but also yield a low number of false positives.
The article shows that the RECAF + CA125 test combination detects ¾ of ovarian cancer stages I & II with no false positives, thus providing, for the first time, a blood test with potential for ovarian cancer screening. It should be noted that while in the USA there are only 22,000 women diagnosed with ovarian cancer each year, the number of women to be screened periodically is very large.
In addition to the results obtained in early stages, the study also showed that using the test combination on patients with late stages (III and IV) of ovarian cancer - at which most patients are currently diagnosed – detects 88% of cancers, again, with no false positives. This is important because the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists issued a recommendation that patients be referred to a gynecological oncologist when specific indicators of malignancy are present. The surgical outcome is better when the surgeon is a specialist and therefore knowing if the patient has cancer before surgery is crucial. This is the FDA approved use of the OVA1tm test combination offered by Vermillion® and Quest Diagnostics® for $650.
One of the manuscript's peer reviewers commented: "I find it a compelling story and well documented." Another reviewer added: "[The manuscript] presents interesting data regarding tumor markers and ovarian cancer. The absence of false positives is impressive and the suggested procedure could improve both monitoring and screening of this disease. It is a pleasure to accept it."
The full article can be found at:
http://www.springerlink.com/content/y662152100073x41/
About BioCurex, Inc.
Gosh when you put it that way, nothing is on the list at all for Recaf. May be His work was not accepted at all for the presentation or for publishing in the low impact Biology circular. Dr. Moro will be back in the office Monday. May be you can call him on this one...Let me know what you find out.
Thanks
Looks to me that these scientists are more interested in mice and nervous chickens than they are about a cancer cure. What is your take?
That's what Gold was trying to tell you. Recaf is just a front for Dr. Moro to go on vacations. The entire ISOBM is actually an international travel agency. I am told the test tubes actually have shots in them..
Spain, Italy, Germany, ....it just goes on and on. In fact, I am thinking of coming up with my own molecule to present via a Poster next year and will be entering for the junior Abbott award. Just bought a scientist outfit which looks awesome.
You can verify all of this by calling Biocurex. Give them the code name. "I Heart DRE's" and they will fill you in.
Gold, that is another incorrect statement.
Gold stated,"Moro has never taken a poster to any other conference besides the ISOBM"
Hungryleon stated,"I did not see any press release saying that he was invited to speak or to present the posters"
Dr. Moro added, "I am also flattered by the congress organizers' invitation to co-chair a panel of the statistical process of discovering and validating new cancer markers. The concepts I will present have been used at BioCurex in our research and development program relating to our RECAF cancer tests."
"We have previously shown that the RECAF cancer test can be used in a variety of ways including screening and diagnostics," stated Dr. Moro. "In this presentation, our results indicate that the RECAF test could also be used for predicting outcome or monitoring treatment for cancer recurrence. We show that this test has a high sensitivity and specificity in early stages of at least two of the most common types of cancers, prostate and breast, as well as the less frequent ovarian cancer. This strongly suggests that a RECAF positive test might precede the clinical expression of a recurrence and therefore allow the oncologist to detect recurrence and treat patients earlier."
The European Group on Tumor Markers Recommendations (2005) state that markers for breast cancer should be determined every 2--4 months (according to the risk of recurrence) during the initial 5 years after diagnosis, then every 6 months during the next 3 years and at yearly intervals thereafter(1). That represents 15-30 tests per cancer patient during the first 5 years following diagnosis and 2 additional tests per year thereafter. This highlights the importance of an inexpensive, reliable cancer marker test and monitoring tool which BioCurex believes could be fulfilled by its RECAF blood test.
Dr. Moro added, "I am also flattered by the congress organizers' invitation to co-chair a panel of the statistical process of discovering and validating new cancer markers. The concepts I will present have been used at BioCurex in our research and development program relating to our RECAF cancer tests."
By the way Gold, you never did respond to my posts? You know the ones where practicing doctors were not fans concerning watchful waiting.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67941995
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67982296
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67982776
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67982136
Gold stated, "Hungryleon, Moro has done oral presentations on RECAF for about the past 7 years but nothing ever happens."
Gold if you were given over $1,500,000 from Abbott and Alere, would you tell your business partners that nothing ever happened?
Where do you think that relationship began at?
Hungry posted,"I'm a scientist and business student"
Has your work been approved and printed in any high impact Journals? or any Journals?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67645175
Hungryleon,
Who is speaking on Wednesday Hall #2 at 12:00
See link below
http://www.isobm-conference.org/wednesday.html
Hungryleon, Following are the distinguished members of the ISOBM organization in which Dr. MORO is also listed. These are not small time names in the industry.
Click link Below
http://www.isobm.org/membership/isobm-members.html
So I do not understand your comment," Dr. Moro is a medical doctor with some training in science."
Hungryleon, These small companies represent the Corporate members of the ISOBM that sponsor and continue to invite Dr. Moro (BOCX) to the events.
Your statement, "So why nobody in the scientific community is researching RECAF if it is such an important molecule?"
Please click on link below
http://www.isobm.org/corporate-member.html
Hungryleon,
We will need to go through your post in stages.
First you state," They are also published in very low impact factor journals, that is another standard to measure scientific relevance."
Please see the link below and let me know if you believe this journal to be in the "in very low impact factor journal" category.
http://www.isobm.org/the-isobm-journal.html
A Publication of the James Buchanan Brady
Urological Institute Johns Hopkins Medical Institutions
Volume II, Autum 2005
Scandinavian Study Shows Prostatectomy Patients Do Better, Live Longer
When men with curable prostate cancer —disease that has not spread widely beyond the prostate — undergo radical prostatectomy, they are much less likely to have the cancer come back, and much less likely to die of the disease than men who don’t have surgery.
This has been illustrated dramatically by a large Scandinavian trial published three years ago, and by a follow-up report, published recently in the New England Journal of Medicine. The results of both publication shave rocked the way prostate cancer is perceived in Sweden, Finland, and Iceland —where the mainstay of treatment traditionally has been watchful waiting and where, sadly, most men with prostate cancer in those countries eventually die of it. In the first report, nearly 700 men were randomly assigned either to radical prostatectomy or to watchful waiting. The results provided the first concrete evidence of something American doctors had known anecdotally for years — that treating localized disease reduces deaths from prostate cancer. During the average follow-up of six years, twice as many men in the watchful waiting group died of prostate cancer — which meant, the scientists concluded, that radical prostatectomy can reduce prostate cancer deaths by about half. That study brought hope that treatment can make a difference, and the elated scientists anticipated that with a longer follow-up, the differences in cancer deaths between these two groups would become even more clear.
They were right. At 10 years after the study began (the results published in the second paper), half of the men in the watch-
Radical prostatectomy reduced the likelihood of dying from prostate cancer by 40 percent.
ful waiting group had died from prostate cancer. Radical prostatectomy reduced the likelihood of dying from prostate cancer by 40 percent. And the overall survival (including all causes) was significantly better in the men who underwent radical prostatectomy. Surgery was of greatest benefit to men who were younger than age 65 at the time their cancer was diagnosed. In that age group, after 10 years, 19 percent of the watchful waiting patients had died of prostate cancer, but fewer than 9 percent of the men who underwent surgery had died. Also, surgery reduced the risk of local recurrence of cancer by 67 percent, and of the cancer’s spread to distant sites by 40 percent. “The impact on distant metastasisis all the more impressive here,” notes Patrick C. Walsh, M.D., University Distinguished Service Professor of Urology,“because hormonal therapy was given more often to the men in the watchful waiting group than to the men who underwent radical prostatectomy.” The study’s authors concluded: “We expect the benefits of this surgery will increase during longer periods of follow-up.”
One important note about this study: Most — 75 percent — of the Scandinavianmen were diagnosed with cancer advanced enough to be felt during a physical exam, with an average PSA of 13 ng/ml. This is in sharp contrast to the United States today, where 75 percent of men are diagnosed, on average, five years earlier, and at a much more curable stage – with non-palpable cancer, detected because of a change in PSA. However, says Walsh, “Although these men had more advanced disease than we commonly see today in the United States, they are very similar to the men who underwent surgery in the early 1990s, before the wide-spread use of PSA screening.”
In 1992, 104,000 men underwent a radical prostatectomy in the United States, Walsh continues. “If we apply the outcome from the recent Scandinavian trial to these figures, we would expect that there would be at least 5,000 fewer men dying of prostate cancer 10 years later, which is close to what we have experienced.” In applying the findings of the Scandinavian study to today’s patients, who are diagnosed with smaller cancers, detected much earlier, the authors note that it may take much longer to see the difference in survival and quality of life, “but the removal of small tumors may facilitate surgery and result in fewer side effects.”
Just before the New England Journal Of Medicine study was published, an investigation by researchers at the University of Connecticut and McGill University in Canada appeared inthe Journal of the American Medical Association.The article made headlines with its authors’conclusion that their findings do “not support aggressive treatment for localized low-grade prostate cancer.” However, the JAMAstudy’s patient population was limited in several ways: First, 60 percent of the patients were diagnosed with low-grade tumors found during transurethral resection of the prostate, a treatment for benign prostate enlargement. “Today these low-grade (Gleason 2-4) tumors are rare,” notes Walsh, “because with the availability of medical therapy, fewer men are undergoing surgery for an enlarged prostate. I haven’t operated on a patient with Gleason 2-4 disease in the last 10 years. What the authors’ data supported, and what they should have stated in their conclusion, was that men with Gleason scores greater than 4 — the vast majority of all men diagnosed today — have a significant risk of dying from prostate cancer, and may benefit from treatment.” Also, this paper did not accurately describe the natural history of untreated prostate cancer, because 42 percent of the patients received hormonal therapy within six months of diagnosis. And finally, because many of the study’s patients also had serious, chronic health problems — when the paper was written, only 6 percent of the patients in the study were still alive, and most had died from other causes — the results aren’t helpful to an otherwise healthy man trying to decide on the best course of treatment for cancer.
(Treatment options are a frequent subject in QUEST. Please use the website search engine for additional coverage of this topic.)
1. Q: Do you feel that a radical prostatectomy offers the best chance for a "cure" of prostate cancer?
A: Yes, I do. That belief is based upon my own published results, the research literature, my own prostate cancer screening studies, and my professional experience.
2. Q: How can Dr. Catalona be reached?
A: I am working at Northwestern Memorial Hospital in Chicago. My telephone number for scheduling surgeries is: 312 695-6126.
3. Q: What is the recovery time following a radical prostatectomy?
A: Usually, the patient is in the hospital for 2 to 3 days. The catheter remains for 10 days. The patient can drive once the catheter is out. No vigorous exercise should be performed for 6 weeks. The patient can return to work after 3 or 4 weeks, but he usually tires easily because of anemia for the first 6-8 weeks.
4. Q: What is the survival rate of prostate cancer patients treated with radical prostatectomy?
A: In the most recent tabulation of my surgical patients, now including more than 4,400 men, the 10-year prostate cancer-specific survival rate is 96%. This statistic means that whether or not there has been a recurrence of the prostate cancer, only 4% of men died of prostate cancer before 10 years after surgery. These statistics are for my patients. General statistics could be different.
5. Q: How can I go about finding a good surgeon?
A: I do not recommend specific surgeons in particular areas of the country, but I would recommend that you ask physicians in your community whom they would recommend and also that you check at some of the high-volume prostate cancer centers for information about their surgeons.
You want to know how frequently they perform nerve-sparing surgery and how many surgeries they’ve performed. Most doctors do not keep statistics on their operations, but I think it is reasonable to ask to talk with 10 previous patients of that doctor. Most surgeons should have a list of patients who have given their consent to be contacted by potential patients.
6. Q: Once prostate cancer is diagnosed, how long is it safe to wait before having surgery to remove the prostate?
A: It is impossible to tell how long is safe. Obviously, it is best to have treatment as soon as convenient. Some patients delay for 3 to 4 months for various reasons. Hormonal therapy may be indicated for longer delays; however, hormonal therapy can make it more difficult to perform nerve-sparing surgery because it causes scarring around the prostate gland.
7. Q: Is there any benefit beginning Kegel exercises prior to radical prostatectomy?
A: The short answer is “yes.” I believe that it will pay dividends to strengthen the muscles before surgery.
8. Q: What is nerve-sparing surgery? And which patients are candidates?
A: The nerves are like railroad tracks with the prostate being like a boxcar on top of the tracks. In this surgery, doctors try to gently lift the “box car” off the railroad tracks without damaging the “tracks.” If the cancer is detected early, then the prostate can sometimes be removed very nicely without disturbing the nerves. The nerves usually get bruised and stretched somewhat during the operation, which is why it can take 3 to 6 months for erections to begin to return after surgery. But with time, the nerves regenerate so it’s very important to detect the cancer while still on the inside of the prostate before it grows out into those nerves. Once it’s grown out into the nerves, it’s not possible to spare the nerves.
Patients who have good erections preoperatively and desire to remain potent are reasonable candidates for nerve-sparing surgery if their PSA is low, their Gleason grade is not too high, and their prostate examination does not suggest that the cancer has spread beyond the prostate gland. The final decision to do nerve-sparing surgery is usually made by the surgeon during the operation.
9. Q: Is a cat scan (CT) of the pelvis necessary before surgery?
A: Most surgeons would say a CT is not necessary; however, I like to have a CT before surgery to ensure that no other important medical conditions are present that might affect the planned operation.
10. Q: Can surgery spread the prostate cancer?
A: Usually, a surgeon does not cut into the prostate gland during removal of the prostate. Although it is theoretically possible that cutting into the prostate could encourage cancer cells to spread, prostate cancer is not a type of cancer that “implants” easily into other tissues. This worry would be much greater with some other types of cancers.
11. Q: What is follow-up radiation (post-operative radiotherapy) and why would it be needed after a RRP? (More information on this topic is included in the FAQ category: Post Operative Treatment and Treatment Upon Recurrence.)
A: Sometimes, it is strongly advised when the pathology report shows positive surgical margins or extension of the tumor beyond the prostate gland.
Also, it is often advised when the PSA begins to rise after surgery.
There are two types of follow-up radiotherapy. 1. Adjuvant radiotherapy is given as a precautionary measure in patients who have adverse features in their pathology report. This radiotherapy is usually given 3 to 4 months after the operation when urinary continence has returned. It may be delayed further if continence has not yet returned. 2. Salvage radiotherapy is for a rising PSA, which means a recurrence of the cancer. This radiotherapy should be given before the PSA level rises above 1ng/ml.
12. Q: Can other medical conditions affect the option of a radical prostatectomy for treatment of prostate cancer?
A: Yes. Some serious ailments make a patient too great a risk for surgery. Even though I believe that surgery might be the best treatment for a tumor, it is not always the best treatment for the patient. This decision is best made in consultation with the surgeon and other physicians of the patient.
13. Q: Is "watchful waiting" a treatment option after a diagnosis of prostate cancer?
A: In my opinion, the answer is no, except for older men with low-grade tumors that are not very threatening.
For the vast majority of men with prostate cancer, early definitive treatment is indicated.
Some of the public information about prostate cancer is misleading. It suggests that prostate cancer is a toothless lion, i.e., that more men die with it than of it.
There is a difference between a dead man whose prostate is found to contain cancer when it is extensively examined at autopsy and a living man whose cancer has been found because of an elevated PSA or abnormal digital examination. And the younger a man is, the more likely he will benefit from being cured.
It is most likely that a clinically detected prostate cancer will progress with time. For example, waiting for a PSA to get up to 6-7 risks a 30% chance that the cancer would have escaped from the prostate at the time of treatment.
Currently, there are watchful waiting studies of young men. It is called “active monitoring.” If the PSA rises or repeated biopsies show more cancer or high-grade cancer, then treatment is initiated. The downside of this approach is that for men whose cancer ultimately requires treatment, it is treated at a later time and the repeated biopsies can me it more difficult to perform nerve-sparing surgery.
14. Q: What do you think about brachytherapy (seed implantation) compared to standard surgery?
A: I do not believe it is as effective as surgery. (Use the search engine in this website to find comparisons and studies for brachytherapy.)
15. Q: What do you think about cryoablation as a treatment for prostate cancer?
A: I do not believe that cryoablation (controlled freezing of the prostate gland in order to destroy cancerous cells) is an effective primary treatment for localized prostate cancer. Some advocate it for men who have failed radiation therapy. It almost always results in impotency. Also, a major concern is that if cancer cells are near the urethra, the warming of the urethra (as a protection against freezing and a consequence of the thawing process after the freezing) allows the cancer cells to survive. Frankly, I do not recommend cryoablation to any of my patients.
16. Q: Is it a good idea to use hormone therapy before or in conjunction with surgery? What does it do in this situation?
A: Hormonal therapy is used by some doctors to shrink the cancer before surgery. Available evidence suggests that while hormonal therapy makes it more likely that the surgical margins will be “clear,” no convincing evidence exists to show it reduces tumor recurrence rates.
A possible disadvantage of hormonal therapy before surgery is that it may cause scarring around the prostate gland that sometimes makes it more difficult to perform nerve-sparing surgery.
17. Q: Can you comment on the pros and cons of robotic laparoscopic surgery versus conventional open surgery?
A: Laparoscopic radical prostatectomy is feasible. It is performed at several centers throughout the US, including my institution. It is now considered to be in its “infancy.” However, I do not believe there are any material advantages for the patient compared with open radical prostatectomy.
In my opinion, it is far more difficult to get consistently good results because it does not afford the surgeon as much control as with the traditional operation. Also, it does not provide tactile feedback, and it is more difficult to suture laparoscopically.
With robotic surgery, suturing is less difficult, but it still has limitations of access and lack of tactile feedback. The surgeon cannot tell how hard the robot is grasping tissue, or, if the angle of the needle is wrong and if the needle does not pass through the tissues easily, the robot continues to “muscle” its way through.
With tactile feedback afforded by open surgery, the surgeon would “feel” the mistake and make the necessary adjustment.
At present, information is insufficient to determine whether long-term results will be as good as with standard nerve-sparing radical prostatectomy, especially in terms of preserving sexual potency and obtaining cancer-free surgical margins.
Having seen laparoscopic and robotic surgery performed by most of the world’s most experienced experts, I don’t believe it allows nerve-sparing to be performed with the same degree of fine control without risking thermal damage to the neurovascular bundles, and I do not believe removal of the cancer is as consistently complete.
18. Q: What are treatment options for a diagnosis with a high PSA and a high Gleason score?
A: With “high risk” prostate cancer, it is unlikely that the cancer can be cured by surgery or radiation alone. Options would include something as conservative as intermittent or continuous hormonal therapy or aggressive treatment with combinations of surgery, radiotherapy, hormonal therapy and/or chemotherapy.
19. Q: How far off do you think gene therapy is for the treatment of prostate cancer?
A: I am often asked this question by patients. I believe that gene therapy will be developed first as a potential treatment for patients with the most advanced stages of prostate cancer for whom no other effective therapy is available. Then if gene therapy works in these patients, it will be moved into the realm of treating earlier stages of the disease.
Although exciting research is underway in gene therapy and other experimental treatment approaches for prostate cancer, I do not believe it is overly conservative to state that practical application of these new techniques is probably several years away.
20. Q: What is external beam radiotherapy and how are treatment results different from those of a radical prostatectomy?
A: In this method, x-ray treatments are given with a machine that sends high-energy x-rays through the patient’s body, aimed at the prostate gland and sometimes the pelvic lymph nodes.
External beam radiotherapy is a totally non-invasive treatment used as an option for men who are considered too old or too ill for a prostatectomy or who just don’t want surgery.
It is difficult to determine whether external beam radiation actually eradicates all of the prostate cancer because many patients in whom progression of the tumor is slowed or halted have persistent tumor on repeat rebiopsy. The best results are obtained when tumors are less than 2 centimeters in size at the time of therapy.
21. Q: What is the difference between a retropubic (RRP) and a perineal (RPP) prostatectomy?
A: Both approaches can yield good results if the surgeon is experienced and has expertise in performing the operation.
In a radical perineal prostatectomy, the prostate gland is removed through an incision in the perineum, the area between the scrotum and the anus.
In a radical retropubic prostatectomy, the surgeon makes an incision in the lower abdomen to remove the prostate, which is located retropubically, or behind the pubic bone.
The principal advantage of the retropubic approach, in my opinion, is that the cavernosal nerves are more readily spared, because from the retropubic approach the prostate gland is lifted up off the nerves. In the perineal approach, the gland must be pulled down between the nerves.
Another advantage of the retropubic approach is less chance for injuring the rectum during the surgery and less chance of postoperative rectal incontinence.
22. Q: What is IMRT radiation and is it an alternative to a radical prostatectomy?
A: IMRT (Intensity-Modulated Radiation Therapy) is one of the best forms of radiation therapy. It is computer-controlled radiation that delivers precise doses to malignant tumors or specific areas within a tumor with minimal effect on other tissue. The technology allows for higher and more effective doses to be delivered without damaging surrounding tissue.
But there is a statistical issue about how the results are reported that make them appear 10% to 20% better than they really are. I do not believe that IMRT is as effective as surgery in appropriately selected patients.
23. Q: What information should I receive from my doctor when I’m diagnosed with prostate cancer?
A: You should be told the tumor stage (which tells how far it has spread) and the tumor or Gleason grade (which tells how aggressive it is or how fast it is growing).
You should also be given treatment options for your particular tumor and then recommendations for the preferred treatment for that tumor. A list of treatments available to everyone is not particularly helpful to an individual patient. Good decisions are made based upon specific tumor characteristics.
24. Q: What do you think about the recent reports on the immunotherapy drug, Provenge and its use in treating advanced prostate cancer or any prostate cancer?
A: I am skeptical about the efficacy of Provenge.
In the early studies, it only showed a benefit in patients with advanced, but low-grade prostate cancer. The great majority of prostate cancer patients with advanced disease have high-grade cancer.
I would be surprised if Provenge has much to offer.
25. Q: Often the material about determining the incidence and severity of the side effects of a radical prostatectomy refers to the "experience" of the surgeon as the most important factor.
How does a prospective patient interpret "experience?"
A: In my experience, most patients have three main priorities concerning their treatment outcomes, usually in the following order:
1) to survive prostate cancer 2) to recover urinary continence, and 3) to recover erections. This threesome has been called “achieving the trifecta.”
Of course, men have other secondary priorities, such as the discomforts associated with treatment, the time required for recovery, and the time to return to normal activities.
All of these priorities are important, and different surgeons (and different treatments) vary in achieving them.
Few surgeons keep accurate tabulations of their outcomes. Not surprisingly, studies have shown that high-volume surgeons generally (but not always) achieve better results.
One practical solution for the prospective patient is to be diligent in finding out about the experience and reputation of the surgeon.
He should also ask the surgeon to provide the contact information of 4 or 5 of his or her patients who have had good outcomes (I routinely ask my patients whether they are willing to be contacted by prospective future patients, and most are happy to do so and sign a HIPAA release form).
If several patients are pleased with their outcomes, it shows that at least in these cases, the surgeon was able to achieve good results.
26.Q: Do men with prostate cancer ever have radiation prior to a radical prostatectomy?
A: Planned preoperative radiation therapy is not used in treating prostate cancer because radiation damages the blood supply to the tissues so they do not heal as well after high doses of radiation.
Such radiation makes the complications and side effects of radical prostatectomy far more likely than if the tissues had not received radiation.
Sometimes, so-called “salvage” radical prostatectomy is performed in patients who were treated initially with radiation and subsequently have a cancer recurrence. Salvage prostatectomy is associated with a far greater risk for complications and is substantially less likely to cure the cancer.
27. Q: What is a man supposed to do who is diagnosed with prostate cancer but has no medical insurance and a low income?
A: The options are a Veterans Administration Hospital (if a veteran) or a public hospital, such as a county or city hospital.
In addition, almost all private hospitals provide low-cost or free care to some patients who have no health insurance and a low income. Men in such a situation can call urology departments of private hospitals to see what options are available.
Also, many private hospitals have social work departments and the staff there is trained to help with special needs. Men can ask to see someone in that department for advice.
28.Q: If I choose external beam radiation and the cancer does not go away, can I later have the prostate removed?
A: It is possible to remove the prostate gland after radiation therapy, but the complication rate is far higher (25% to 50% risk of incontinence, almost certain impotence, and a significant risk for rectal injury during surgery that might require a temporary or permanent colostomy).
Accordingly, most surgeons, including myself (Catalona), do not perform salvage prostatectomy.
29.Q: Can IMRT (intensity modulated radiation therapy), the high-powered radiation that can be directed to very particular areas, be used as the sole treatment for prostate cancer?
In other words, can I have IMRT and not have a radical prostatectomy?
A:IMRT can be used as the sole treatment for prostate cancer.
In fact, it is one of the most effective forms of radiotherapy for treating prostate cancer.
However, in my opinion, it is not as effective as surgery for treating organ-confined tumors that might be resistant to therapeutic doses of radiotherapy, and it does not prevent future new cancers from developing in the prostate gland.
30.Q: Is there sufficient track record and statistics to evaluate success rates for robotic surgery in the treatment of prostate cancer?
A:In my opinion, the results with robotic surgery are not as consistently good as they are with open surgery by a surgeon who specializes in nerve-sparing radical prostatectomy.
Robotic surgery is being aggressively marketed all over the country, and there are claims that robotic surgery is as good, but I do not believe that it is true.
31.Q: How many types of tests do you recommend taking prior to the decision to have surgery?
Whenever I read an article about prostate cancer, I learn about a new test.
A:How many tests are indicated before proceeding with treatment is a controversial subject. To some extent, it depends on the individual's risk for having cancer that has spread.
For instance, if the patient has a low PSA, low Gleason grade and normal feeling prostate, some would argue that no further testing is indicated, including lymph node biopsy.
On the other hand, if the PSA or Gleason grade are higher, further testing such as a bone scan and abdominal and pelvic CT or MRI scan might be indicated.
Some of the tests currently available, such as Prostascint, ploidy, PAP, color endo-rectal MRI, complexed PSA, provide little additional useful information, in my opinion.
I am usually comfortable if the patient has a bone scan with appropriate follow-up imaging studies of any abnormalities that might appear and an abdominal-pelvic CT scan.
32.Q: My understanding is that 72% of prostate cancer starts in the peripheral zone, 20% starts in transition zone and 8% in the central zone. Has there been any research which would indicate whether it is more difficult or any easier to treat prostate cancer which started in the transition zone or the apex zone as opposed to the peripheral zone?
A:In general, it is believed that prostate cancer that arises in the peripheral zone is more aggressive than that which arises in the transition or central zones. The apex includes the transition and peripheral zones.
33.Q: Is it always important to give my own blood in preparation for prostate cancer surgery?
A:The blood bank blood is now very safe, but nothing is safer than your own blood. I usually have my patients store one pint of their own blood, which I usually give back to them after surgery, and it is very unusual for them to have to receive blood from another person.
34.Q: As I wait over 3 months for surgery (grinding my teeth more each day), I am told that statistically my cancer has not moved out of the gland. What makes up such statistics and how much can I count on them?
A:Several tables called "nomograms" provide information on the probability that a tumor would be totally contained within the prostate and whether or not there will be a later recurrrence.
These tables are called Partin tables, Kattan tables, or D'Amico tables, named after the authors who devised them.
They contain an estimate of the probability, but there can be variation around these estimates.
Factors to determine the likelihood that the tumor would be "contained" are: the Gleason grade, the PSA level, the rectal and ultrasound examination findings, the bone scan findings, and the number of biopsy cores involved with cancer, the percentage of the biopsy tissue involved with cancer, and whether or not the pathologist saw "perineural involvement" on the biopsy specimens.
In general, I believe that these tables provide a slightly pessimistic estimate, because as time goes on, prostate cancer is discovered earlier and earlier.
35.Q: I was told by others that I will be asked to decide what I want the urologist to do if he finds evidence of prostate cancer in the lymph nodes. Is there only one kind of spread to the lymph nodes, and what is my best decision?
A:Now that we are detecting prostate cancer much earlier due to PSA testing, it is rare to find lymph node metastases.
Predictors of lymph node involvement are high PSA level (greater than 20), Gleason grade higher than 7, many biopsy cores containing cancer, and a very abnormal feeling prostate on digital rectal examination.
Lymph node biopsy is not mandatory in the absence of any of these features. My policy is to remove a small tissue packet containing 1-3 of the so-called "first echelon" lymph nodes near the prostate.
Lymph node involvement is an unfavorable prognostic sign. However, two small case-control studies from Johns Hopkins and the Mayo Clinic suggest that the outcome is better if the prostate is removed in patients with minimal lymph node involvement. About 95% of my patients elect to proceed with removal of the prostate even if the lymph nodes are involved.
36.Q: My father is 72 years old and in good health. He visited a urologist because he had trouble urinating. The diagnosis was prostate cancer. My father says that he has a good life. Why destroy everything by taking all of the treatments? Is 72 years old too old for surgery?
A:At age 72, your father still has a 10-year life expectancy that could be shortened by prostate cancer. Age 72 is "borderline" for a radical prostatectomy, but if he were otherwise healthy, he would be a legitimate candidate for the operation.
There is no reason to believe that surgery would "destroy everything," if he chooses a good, experienced surgeon. His other option for cure would be radiotherapy. Hormonal therapy would almost certainly slow the progression of the cancer, perhaps for the rest of his natural life, but that result could not be guaranteed.
37.Q: Can a person wait as long as six months to decide whether or not to have surgery for prostate cancer that is low Gleason score and low volume?
A: Yes and No.
If the biopsy suggests the cancer is low volume and low grade, the final prostatectomy specimen will confirm this impression 80-85% of the time.
However, the biopsy is only a sample, and in 15-20% of cases, there will be significantly more cancer or cancer at or beyond the margin of the prostate gland or higher Gleason grade cancer.
Therefore, I advise my patients to wait only 6 weeks after the biopsy to let the inflammation subside and then schedule surgery as soon as they conveniently can schedule it.
38. Q: My doctor recommended robotic removal of the prostate but, after reading about the technique, I have reservations about it. What am I supposed to tell my doctor or do I just go to another doctor?
A: You could refer to the article appearing in the Fall 2010 Quest (page 10) and see what the response is or select another experienced surgeon who specializes in open nerve-sparing radical prostatectomy.
39. Q: Are there potential methods for predicting aggressive prostate cancer?
A: Many good ones are in use every day including free and total PSA, PSA velocity, PSA density, Gleason grade, amount of cancer in biopsy specimens, findings on prostate exam, ultrasound, CT or MRI scans. Other new tests include the [-2] ProPSA test (waiting for approval by the FDA).
These tests all are useful in predicting the aggressiveness of a prostate cancer.
Where the real problem lies is in patients who appear to have low-risk tumors (Gleason of 6 or less, low amounts of cancer in the biopsy specimens, and PSA less than 10). One-third or more of these tumors will ultimately prove to behave aggressively.
How can we better identify the wolves masquerading as lambs? This answer is perhaps the holy grail of current prostate cancer research.
(See page 1 article in the Winter 2010 Quest: Which Prostate Cancers Are Aggressive and Which Aren’t?)
40. Q: Before performing a radical prostatectomy, is it an acceptable practice for one hospital/surgeon to use another hospital’s biopsy report and not do their own?
A: My hospital requires that our pathologists confirm the diagnosis.
41. Q: What is your opinion on attempting to shrink the prostate before having a prostatectomy as soon as possible?
A: I would not advise this practice. Trying to shrink the prostate with hormone therapy sometimes causes scarring around the prostate that makes it difficult to perform a nice clean nerve sparing operation. Also some prostate cancer cells are resistant to hormone therapy and if they are present, they could continue to grow and perhaps spread during the six months. In my opinion, one should be wary of using drugs that are not approved for prostate cancer treatment unless the reason is very compelling.
Return to Frequently Asked Questions
Actually Gold, if one could prove to me that it would never develop into full blown cancer then there would be no reason to yank it out. The issue becomes that with cancer you only get one chance and therefore it is best to error on the side of caution which leads to treatment. remember though that one is not limited to yanking it out....
They have radioactive seeds that can be implanted or one can do the watchful waiting....that is up to the patient.
Gold, ultimately the cancer if present may or may not spread. However it is a lot easier to treat prior to spreading and is proven to extend life if diagnosed early and removed prior to metastasis.
My Mother's debunking surgery removed a lot of the cancer but two each 2cm areas were seen but left in tact as they were attached to critical areas.
Had she been diagnosed earlier they could have removed the ovaries only while it resided only in the ovaries.
In regard to your post, the absence of Recaf combined with the PSA would deprive those who want early detection of a better test.
Prostate cancer is common among American men. In 2004, nearly 300,000 American men were diagnosed with prostate cancer and among these, approximately 30,000 died. If anything, these statistics show that prostate cancer, for most patients, actually does have a good prognosis.
As with any other form of cancer, early detection plays an important role in the outcome of the treatment that has been administered, the prognosis of the disease, and the life span of the patient. This is why it is highly recommended that you get screened annually by your physician. Catching cancer in the earliest stages will make the prognosis much better.
Metastatic Cancer
Metastatic cancer is cancer that has spread from the initial area to other parts of the body through the bloodstream or the lymph system. This happens because a cancerous cell has broken away from the mass where it was initially located and has migrated to another part of the body where it has continued to grow.
Metastatic cancer is actually later stage cancer. Cancer that is not detected until, the later stages can be difficult to treat and the curability rate lowers, as does the survival rate.
Survival Rate
Men who experience metastatic prostate cancer have less than a 10% chance of surviving for another five years after the diagnosis has been made. However, cancer is different in every patient, and each patient is also different from every other patient. So every person who has metastatic prostate cancer will not necessarily experience the same prognosis. Studies have shown that the location of the tumors, among other things, can affect the prognosis and that some men who have metastatic prostate cancer have a 20% to 30% chance of survival after the first five years of diagnosis.
Treatment
Treatment options are available for late stage of this cancer; however, it is harder to treat than the earlier stages where the cancer is more localized. Even if this cancer can be treated through radiation therapy or chemotherapy, the chances for recurrence are high. Recurrence is usually when you experience metastases. Patients who experience metastases are likely to receive a bad prognosis. When cancer metastasizes, sometimes there are just too many cancerous cells and they end up disrupting the body's metabolism, eventually resulting in death. At other times, the cancer can metastasize into vital areas of the body, such as the brain, and then result in death.
The surgical treatment option is usually thrown out the window in cases where the cancer has metastasized, but not in all cases. If the cancerous cells are large in number, push on vital organs, or intertwine themselves around delicate structures, surgery is not an option.
Late stage cancer can be treated; however, the prognosis is not good. Metastatic prostate cancer is late stage cancer and the prognosis of survival after the first five years after diagnosis is very low compared to the other stages.
Hmmm it seems that the DRE is very similar to the PSA. They both provide the doctor with information where a decision needs to be made which could lead to a Biopsy.
There is that silly Biopsy word again.
What Happens If Your Digital Rectal Exam Is Abnormal?
The digital rectal exam is most helpful when it is coupled with the PSA test. If your PSA is high or increasing quickly, then your doctor will likely choose to test you for prostate cancer regardless of what the digital rectal exam shows. This is because, unfortunately, some men develop prostate cancer without any detectable abnormality on their digital rectal exam.
If your PSA is normal, but your doctor detects an area of increased hardness or a nodule, then he will likely choose to do a biopsy at a later date to determine whether or not this area is the result of prostate cancer. Only a biopsy can definitively determine if a man has prostate cancer.
If you PSA is normal or elevated and your prostate is simply enlarged without an area of hardness or a nodule, then your doctor may simply attribute this to BPH (a benign enlarged prostate). He may, however, want to do a biopsy to rule out prostate cancer.Prostatitis, a temporary inflammation of the prostate that is not cancer, can also cause the prostate to swell and become tender on the examination.
What's the Bottom Line?
The digital rectal exam provides considerable information to your doctor about the health of your prostate, but it is not a perfect test. When combined with the PSA test and other information about your health, it can help to guide your doctor to order more testing (such as a biopsy) so that prostate cancer or other important prostate conditions can be diagnosed early.
Gold At least answer this...
you subscribe to the Digital Rectal Exam.
Lets say the results come back irregular. Now what is the next logical step for the doctor and for the patient?
So Gold, what your saying is...
When the red light illuminates on your car's dashboard (Recaf positive) and says the engine is overheating (cancer is present) then it is the red lights fault when you continue to drive the car without researching the issue? And still the red lights fault if you do pull over and inspect the issue?
The problem could be a short in the red light circuit (Recaf Test) or it could be:
1 your radiator is low on coolant (early prostate cancer)
2 the thermostat could be stuck closed on your coolant system (early breast cancer)
3 you are completely out of engine oil (early ovarian cancer)
So when your car grinds to a halt and your head is warped, your engine locked up, your bearings are frozen up and you throw a rod through the side of the engine...it is obviously the red lights fault? Oops that is going to cost a pretty penny...
You are saying that the Red light should no longer be installed in newer cars because it may cause one to research a problem and that would be an inconvenience to the public.
Do you want to pay $4 dollars for a quart of oil or do you want to pay $6,000 dollars for a new engine?
The commission, the U.S. Preventive Services Task Force, doesn't dispute that the test detects cancer. Instead, it argues, with a formidable arsenal of data, that the test leads to widespread over-treatment, which outweighs the benefits of early detection. Over the entire society, it says, there is no net gain and substantial damage to patients, ranging from needless worry, to impotence and incontinence, to death.
USA TODAY OPINION
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Opinions expressed in USA TODAY's editorials are decided by its Editorial Board, a demographically and ideologically diverse group that is separate from USA TODAY's news staff.
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And therein lies a dilemma for the older-than-50 male, for whom averages mean little.
If he isn't tested, he'll be spared the false positives the test commonly produces as well as treatment risk. On the other hand, if he has high-grade cancer, the disease might not be found until it has spread to other organs, which is fatal. The five-year survival rate for localized prostate cancer is 100%. Once the cancer reaches distant organs, the rate falls to 28.8%.
The panel's data make a compelling case that the overall societal benefit from widespread PSA screening is marginal, and it is not the first group to say so. In fact, the skeptics include the man who invented the PSA test. So in statistical terms, the diagnosis appears sound. But in tallying the damage, the commission makes some relatively small problems seem very big.
Yes, knowing you might have cancer is stressful, but it's better than not knowing. And yes, the biopsies that typically follow a rise in PSA can be painful, but for most patients they're not. As for the major complications — urinary incontinence and erectile dysfunction — they're usually temporary and highly treatable. They're also a lot better than being dead.
More troubling is the commission's solution.
It proposes eliminating the information that leads to over-treatment, rather than reforming the treatment itself. This is necessary, says the panel's chairman, Virginia Moyer, because once patients hear they have cancer, human nature drives them to demand aggressive action, necessary or not, and because engineering massive change in medical practices is a Herculean task.
She has a point, but ignorance is not bliss. It leaves the poor fellow with undetected high-grade cancer as collateral damage. The fact that his death might be statistically offset by the survival of someone who would have died from unneeded treatment is cold comfort.
It's important to note that the commission is not seeking to ban PSA testing. It just wants an end to routine screening. Doctors would still administer PSA tests when symptoms and risk factors warrant. Still, depriving people of information that empowers them to make choices is disturbing. Even more so because the panel's work has broader implications.
With the cost of American health care wildly out of control, the hunt is on to reduce unproductive treatments. The prostate recommendation, like the commission's equally controversial suggestion in 2009 to do fewer mammograms, is a measure of how difficult that discussion will be.
Meanwhile, at the risk of practicing medicine without a license, here's our suggestion for the 50-plus male: Get tested, then get smart. Information about prostate cancer and its treatment is readily available from the National Cancer Institute, major cancer centers and other sources.
Being left in the dark — whether by choice or medical fiat — is not a helpful option.
For more information about reprints & permissions, visit our FAQ's. To report corrections and clarifications, contact Standards Editor Brent Jones. For publication consideration in the newspaper, send comments to letters@usatoday.com. Include name, phone number, city and state for verification. To view our corrections, go to corrections.usatoday.com.
I hear you Dog...I just get a little agitated when the facts get twisted around.
Dr. Moro and crew have a great diagnostic test. I do not like when it is degraded.
Maybe Dr. Moro will be able to improve the Biopsy process some day in the future with the next aspect of Recaf (Imaging of cancer).
OOPS.
Gold the proper statement might be:
Recaf does solve the problem with PSA.
PSA finds some cancers that could be treated but it also finds non cancerous issues which do not require Biopsy. RECAF does Verify the situation because it would find growing cancers also while preventing a tremendous amount of unnecessary biopsies from say only enlarged prostates. RECAF would make the problem less by preventing unnecessary Biopsies.
Your true argument actually lies in the Biopsy process. This is the point where the doctor should be able to differentiate between slow and fast growing cancers.
http://en.wikipedia.org/wiki/Biopsy
Remember that the prostate is not removed in the Biopsy process...
The diapers and incontinence / erectile disfuncions may happen only after the prostate is removed.
Ask the Biopsy dude why he or she did or did not tell the patient if the cancer was fast or slow growing BEFORE THE PROSTATE WAS REMOVED...
Time for cancer 101 classes again.
1.PSA alerts one to the probability that one may have cancer. This is the same for Recaf, CEA, Ca125, ultrasounds, Pet scans, mammograms, x-rays, DRE's etc. etc
If one does not want to know his or her cancer status, or the potentials for early diagnosis then he or she could forego any of these tests. This points to two outcomes.
A. They never get cancer
B. They find cancer in the advanced stages when the outcome of treatment is poor. Don't blame the test...its only job is to provide early warning of potential cancer.
2. The cancer tests DO NOT DIAGNOSE CANCER !
This is the job of the Biopsy.
Even following a surgery where tumors are taken off or out of the body, the doctor can not say the masses are cancer UNTIL THE BIOPSY IS COMPLETED.
If you want to blame a process for overtreating...Here is your chance. The BIOPSY DETERMINES the cancer and is a large part of staging the cancer and its slow or fast growing potential.
Again...No one forced the Biopsy... That was a decision made by the patient in conjunction with the doctor and the family / friends.
3. Following a biopsy...
One has choices..
A. Removal and or Treatment
B. Watchful waiting
C. Absolutely Nothing at all.
Don't Blame the messenger.. The cancer detection test. It did what we all asked of it. Prior to all of these tests people wanted tests for early detection. They paid big bucks for them to be invented and now they have a bunch of them to choose from. None of which are perfect but it is what it is.
So one who does not like cancer tests has many exit points.
1. Don't take any cancer tests
2. Don't get a Biopsy
3. Don't treat the cancer
In summary...Don't blame the test...Even Russian roulette gives you 5 of 6 chances to live. Some may like those odds. I do not!
It is interesting that there are breast cancer awareness events, Prostate awareness events etc. etc. The people raise money for treatment or a cure.. Lots of money at that.
Then they have an opportunity to treat / cure the cancer if it is diagnosed early.
Then you have those that want to bury there heads in the sand and wait for advanced signs of cancer.
When is Prostate treatment necessary Gold?
How does one technically determine if they have stage I or II or so on ?
Does the PSA or the DRE have a little red light on the test to tell you the stage of the cancer?
What if one gets a biopsy...Does the doctor force them to treat the cancer or does he give them options?
The PSA test does no harm to individuals. They are big boys and can make decisions based on many different tests.
Hungry,
The best we have is early detection !!
My Mother just found out a year ago that she had Ovarian Cancer. It was found by accident via an ultrasound.
It was / is considered slow growing....but the Gyno sure missed it and within a few months of her gyno visit, The doctor took about 10 pounds of tumor out. This has been just over a year now. Doc said it is of the slow growing type. The doctor can not however guarantee how slow or fast. Might come back in a few months or maybe never.....They left some of the cancer intact as it was in places that would be difficult to remove without causing other issues...
overtreatment is a monday morning quarterback term IMO. No person can ever prove if a cancer removed would have grown or not grown in a short or long span.
There Are no guarantees in life !!! Nor are there in cancer treatment...
So Gold, Why then do you subscribe to the Rubber Glove test (DRE)
I hope this gets picked up by the Associated Press and is distributed to the masses.
RICHMOND, British Columbia, Oct. 11, 2011 (GLOBE NEWSWIRE) -- BioCurex Inc. (OTCBB:BOCX.OB - News) today announced that the Company believes it is positioned to solve the most pressing issues that have led to a U.S. government-backed panel recommending against routine prostate cancer screening using the PSA (Prostate Specific Antigen) test. The panel concluded that the PSA test used for widespread screening for the prostate cancer causes more harm than good.In extensive studies done over the last several years, the Company's RECAF cancer marker blood test has been shown to detect approximately 70% of stage I, 76% of stage II, 90% of stage III, and 100% of stage IV prostate cancers all with very high specificity. By contrast, in early stages, the PSA test detects significantly lowers percentages of cancers and is very poor (about 50% accurate) at distinguishing an enlarged prostate (Benign Prostate Hyperplasia, BPH) from prostate cancer.
Currently, men over 50 years of age are screened with PSA for prostate cancer. PSA is secreted by the prostate but it is not specific for cancer and therefore benign prostate conditions also show elevated PSA. As a result, two thirds of prostate biopsies are cancer negative and are not necessary.
In a study to be presented at the ISOBM (International Society of Oncology and Biomarkers) annual meeting in October, BioCurex compared the performance of RECAF and a specialized PSA test referred to as the free-PSA ratio to discriminate prostate cancer from BPH, a common benign condition that requires no surgical treatment. The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies.
A prostate biopsy is obtained by inserting 6-12 needles into the prostate. The most common procedure is carried out from the rectum following an enema and antibiotic coverage, using ultrasound for guidance. Discomfort, bleeding and infection are the most common complications. Thus, it is important to minimize the number of unnecessary biopsies while still detecting the highest possible number of cancer cases.
The recent BioCurex study was done using blinded samples from two different sources and showed that the used FDA approved free-PSA tests would have reduced unnecessary biopsies by 11%, whereas the RECAF test, used on the same samples, would have reduced the number of unwanted biopsies by approximately 70% while detecting a comparable percentage of cancers.
About BioCurex, Inc.
BioCurex, Inc. is a biotechnology company that is developing products based on patented and proprietary technology in the area of cancer diagnostics. The technology identifies a universal cancer marker known as RECAF.
RECAF is a molecule that is present on cancer cells but not detected in significant levels on healthy cells or benign tumor cells. It is the receptor for alpha-fetoprotein and is classified as an oncofetal antigen due to its presence on both fetal and malignant tissues. This characteristic makes RECAF a more accurate indicator of cancer than most current tumor markers.
BioCurex is commercializing its technology through licensing arrangements with companies that develop and market diagnostic tests for the large automated clinical laboratory setting, through development and marketing of non-automated clinical laboratory tests, through development of rapid, point-of-care test formats, and through marketing of its OncoPet RECAF test for cancer in companion animals.
BioCurex has signed licensing agreements for its cancer detection blood tests with Abbott Laboratories (NYSE:ABT - News) and with Alere (NYSE:ALR - News), formerly Inverness Medical Innovations.
For further information on these agreements visit:
http://sec.gov/Archives/edgar/data/1092562/000100487808000117/sb2amnd4s1april08.txt.
For more information about the Company, please visit www.BioCurex.com.
For more information about OncoPet Diagnostics Inc., please visit: www.OncoPetDiagnostics.com.
Forward-Looking Statements
The Company has not authorized the release of this information in any form that contravenes the Communication Act and will not be responsible for unsolicited massive distribution of this material by e-mail or facsimile by unauthorized parties. Statements in this press release, which are not historical facts, are "forward-looking statements'' within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
Contact:
Investor Relations Contact:DC Consulting(407) 792-3333investorinfo@dcconsultingllc.com
Gold he died at at the age of 82...And it wasn't from Prostate cancer because he had it removed years earlier.
Sorry Gold, not my uncle...and he was treated in his 60's. He told his son to listen to the doctors when his son also had prostate cancer...and believed 100 percent that removing the prostate was the right way to go.
His son had the robot surgery and does not have any issues regarding diapers etc.
Gold, over that same time frame, Almost 600,000 men died of prostate cancer. That is an epidemic.
Maybe the use of Recaf coupled with the PSA will help to advance the test such that the flaws of PSA can be addressed.
This is why I do not trust the studies that are against cancer treatments. It is not possible to actually die of cancer.
FRANCISCO - A copy of Steve Jobs' death certificate made public Monday indicates that the Apple Inc. co-founder died of respiratory arrest.
http://www.cbsnews.com/stories/2011/10/10/scitech/main20118343.shtml
Not so Fast Gold,
Panel's Rejection of PSA Test Spurs Mixed Reaction From Experts
Many still stick by the prostate cancer screen, claiming it saves lives.By Steven Reinberg
FRIDAY, Oct. 7 (HealthDay News) -- News that a key government advisory panel will give a thumbs-down next week to a controversial blood test for prostate cancer is garnering both praise and condemnation from experts.
A draft report due out early next week from the United States Preventive Services Task Force (USPSTF) will recommend that healthy men forego regular prostate-specific antigen (PSA) testing aimed at spotting prostate cancer, the The New York Times and other media outlets reported Friday.
The USPSTF is the same independent group of medical experts that caused a firestorm in late 2009 when they ruled against the use of annual mammographies for average-risk women in their 40s.
The PSA test has been similarly controversial, since its overall benefit in saving mens' lives has been challenged by a number of studies. Among the reasons the USPSTF cited in rejecting the PSA test is that the screen does not save lives and instead can result in unnecessary treatments that can leave men with discomfort, impotence and incontinence.
According to the Times, the task force focused on the results of five trials, the two largest done in Europe and in the United States. The European trial included 182,000 men. Over nine years of follow-up, it found no reduction in deaths due to prostate cancer among men of all ages in the study who were underwent PSA testing. But it did find some reduction in deaths among men aged 55 to 69 who got the blood test.
The American trial, involving almost 77,000 men followed for over a decade, also failed to show an overall reduction in deaths among all the men who were screened.
"Unfortunately, the evidence now shows that this test does not save men's lives," Dr. Virginia Moyer, a professor of pediatrics at Baylor College of Medicine and chairwoman of the task force, told the Times. "This test cannot tell the difference between cancers that will and will not affect a man during his natural lifetime. We need to find one that does."
But Dr. Anthony D'Amico, chief of radiation oncology at Brigham and Women's Hospital in Boston and a prostate cancer expert, said the task force's recommendation is misguided.
D'Amico noted that in the European study, screening reduced cancer deaths among these younger men by 44 percent. The U.S. study also showed a 44 percent reduction in cancer death among younger men, he added. "If they look at all the screening studies, they will find that the people who benefited most from screening were the youngest and presumably the healthiest," he noted.
"The panel has not really appreciated the entirety of the evidence," D'Amico said. "Considering all of the data, it appears that younger or healthier men benefit from PSA screening."
Right now, most men are advised to undergo regular PSA tests beginning at age 50. However, because most prostate cancers grow very slowly and may never prove fatal, the value of early treatment has come into question.
Of course, some prostate tumors are aggressive and can prove deadly. Most experts acknowledge that the real problem, right now, is that there's no reliable test to tell a patient which type of tumor he might have.
Dr. Otis W. Brawley, chief medical officer of the American Cancer Society, also cautioned that the task force's decision is not yet set in stone.
"It is important to keep in mind that under the new USPSTF process, the recommendation is not final until the conclusion of the public comment period and the USPSTFs review of those comments," he said.
According to Brawley, the cancer society pored over the existing body of evidence in 2009 and at that point it determined that it could not conclude whether or not PSA screening saves lives.
"We have long been concerned, and it has been very apparent for some years, that some supporters of prostate cancer screening have overstated, exaggerated and, in some cases, misled men about the evidence supporting its effectiveness," Brawley said. "We need balanced, truthful information to be made widely available to physicians and patients when making important health decisions. Sadly, that has not happened with this disease."
Brawley believes men must have an opportunity to make an informed decision with their health care provider about screening for prostate cancer after they receive information about the uncertainties, risks and potential benefits associated with testing for early prostate cancer detection.
"The ACS also strongly asserted that prostate cancer screening should not occur without an informed decision-making process," Brawley added.
D'Amico, who supports PSA testing, added that while over-treatment based on PSA test results has been a problem, much of that can be eliminated if the test is based on the most accurate PSA results. To make the test more accurate, men should stay away from sexual activity just prior to the test, bike riding, horseback riding and colonoscopy, he said. In addition, they should not have a PSA test if they have a bladder or prostate infection; and should wait at least a month after it has cleared up.
"Also, once a person is diagnosed it doesn't mean that they have to undergo treatment -- they can have a discussion with their physician about the significance of this cancer," D'Amico said. "Diagnosing allows one to have the opportunity to understand whether this is a cancer that requires treatment or not. But, putting your hands over your eyes saying, 'I don't want to know,' actually can lead to unnecessary death."
"I would still recommend an annual PSA, particularly for men who are healthy and under 65," D'Amico concluded.
Another expert, Dr. Lionel L. Banez, also supports continued use of the test. Banez, an assistant professor in the division of urologic surgery at Duke University Medical Center, said "the draft of the USPSTF review does provide evidence that PSA screening reduces prostate cancer mortality -- albeit not in as great a magnitude to be called optimal."
Prostate cancer remains the second most common cause of cancer death in men after lung cancer, Banez noted. "Thus, a slight reduction in mortality could still translate in a substantial absolute number of lives saved. Though it is clear that we still need to find a better test to improve early detection of significant disease and to curtail over-treatment, it is not advisable to discourage use of a currently existing test that is proven to save lives," he said.
More information
For more on prostate cancer, visit the U.S. National Cancer Institute.
(SOURCES: Anthony D'Amico, M.D., Ph.D, chief, radiation oncology, Brigham and Women's Hospital, Boston; Lionel L. Banez, M.D., assistant professor, Division of Urologic Surgery, Duke University Medical Center, Durham, N.C.; Otis W. Brawley, M.D., chief medical officer of the American Cancer Society; Oct. 6, 2011, New York Times)
Copyright © 2011 HealthDay. All rights reserved.
HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.
http://healthfinder.gov/News/newsstory.aspx?docid=657674
Very Interesting...The submission by Biocurex of the pre-Investigational Device Exemption appears to have been completely missed by the investing public....Biocurex has a solution to improve the PSA test that was just degraded in a publication bashing the PSA test that screens for the second leading cause of death in Men (Prostate cancer). The report has come full circle and basically tells us that while Columbus proved the world was round, it is now being proved to be flat again because a panel says it is...
Before the PSA test there was no hope for one with early signs of prostate cancer. One lived his life until he got prostate cancer with all of the symptoms then he died. Then there was a test that was available to catch Prostate cancer early enough to do something about it. Now the panel wants to do away with the test because it is not perfect??? Except nobody told the panel that there is nothing else available to replace it = we would go back to oops another one died....wish we could have seen it coming when there was time to correct it? Duh...
The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies. It would not replace it but would improve upon the PSA as a companion test
Prostate cancer claims approximately 30,000 lives a year in the USA.
A recent European study showed screening reduced cancer deaths among these younger men by 44 percent. The U.S. study also showed a 44 percent reduction in cancer death among younger men, he added. "If they look at all the screening studies, they will find that the people who benefited most from screening were the youngest and presumably the healthiest," he noted.
Now Biocurex after years of studies Submited a Pre-Investigational Device Exemption (IDE) to the FDA for RECAF(TM)
as a companion to the PSA test.
The PSA test is organ specific and Recaf is cancer specific.
Biocurex (OTCBB:BOCX)
Historical Stock Chart
1 Month : September 2011 to October 2011
BioCurex, Inc. (OTCBB:BOCX) announced today that the Company has submitted scientific information and a request for a meeting regarding an Investigational Device Exemption (IDE) to the Food and Drug Administration for the use of RECAF in conjunction with PSA to decrease the number of unnecessary prostate biopsies.
In a previous announcement, BioCurex compared the performance of RECAF and free-PSA to discriminate prostate cancer from benign prostate hyperplasia (BPH), a common benign condition that requires no surgical treatment. The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies. (BioCurex's RECAFTM Blood Test for Cancer Can Prevent Two Thirds of Unnecessary Prostate Biopsies Sep 8th, 2011).
The INTENDED USE in the submission reads: "The serum-RECAFTM CLIA test is an in-vitro device for the quantitative measurement of RECAF (receptor for Alpha-fetoprotein) in human serum. The RECAF test is intended to be used in men aged 50 years or older with total PSA values between 4-10 ng/ml and non-suspicious DRE. The RECAF value can be used as an aid in discriminating between prostate cancer and benign disease. Prostatic biopsy is required for the diagnosis of cancer".
Dr. Ricardo Moro, CEO of BioCurex, stated, "This pre-IDE submission is the first step toward seeking FDA approval of our RECAFTM test. This process is aimed at avoiding errors and detours on behalf of the applicants and therefore, should help to speed the regulatory process."
According to the FDA, the pre-IDE process can be thought of as a "pre-submission" process. It may involve sending analytical or clinical protocols to FDA for review and comment before proceeding with studies. The process may also involve a meeting with FDA to discuss protocols and/or possible regulatory pathways. Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the Agency or the Sponsor. A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. In fact, most in vitro diagnostic devices (IVDs) are exempt from the medical device IDE regulations as long as conditions in 21 CFR 812.2(c)(3) are met.
http://www.canaryfoundation.org/publications/pre-IDE%20integrated%20v03%20030421.pdf
http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm123682.htm#4b and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#pre_ide)
The pre-IDE process is designed to help companies obtain early, informal input on aspects of a future IDE application and offers assistance in establishing the parameters for official IDE applications when unique diagnostic tests involving innovative technologies are being pursued.
About BioCurex, Inc.
BioCurex, Inc. is a biotechnology company that is developing products based on patented and proprietary technology in the area of cancer diagnostics. The technology identifies a universal cancer marker known as RECAF.
RECAF is a molecule that is present on cancer cells but not detected in significant levels on healthy cells or benign tumor cells. It is the receptor for alpha-fetoprotein and is classified as an oncofetal antigen due to its presence on both fetal and malignant tissues. This characteristic makes RECAF a more accurate indicator of cancer than most current tumor markers.
BioCurex plans to commercialize its technology through licensing arrangements with companies that develop and market diagnostic tests for the large automated clinical laboratory setting, through development and marketing of non-automated clinical laboratory tests, through development of rapid, point-of-care test formats, and through marketing of its OncoPet RECAF test for cancer in companion animals.
BioCurex has signed licensing agreements for its cancer detection blood tests with Abbott Laboratories (NYSE:ABT) and with Alere (NYSE:ALR), formerly Inverness Medical Innovations.
For further information on these agreements visit:
http://sec.gov/Archives/edgar/data/1092562/000100487808000117/sb2amnd4s1april08.txt.
For more information about the Company, please visit www.BioCurex.com.
For more information about OncoPet Diagnostics Inc., please visit: www.OncoPetDiagnostics.com.
Forward-Looking Statements
The Company has not authorized the release of this information in any form that contravenes the Communication Act and will not be responsible for unsolicited massive distribution of this material by e-mail or facsimile by unauthorized parties. Statements in this press release, which are not historical facts, are "forward-looking statements" within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
CONTACT: Investor Relations Contact:
DC Consulting
(407) 792-3333
investorinfo@dcconsultingllc.com
Upon completion of the review of the pre-IDE submission, the reviewing division will issue a response to the sponsor in a timely manner, usually within 60 days of receipt.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#fda_action
This could have been a different story with Recaf months or years earlier.
Breast Cancer's Financial Toll: The High
Cost of Fighting for Your Life
By SHERYL NANCE-NASH
Posted 11:00AM 10/05/11 Health Care, Insurance, Personal Finance
Marci found a lump in her breast in April of last year. She went to
the doctor the next day.
"The first doctor I saw told me that it was not life threatening,
probably a cyst, and that I am too young to worry. I was 33 at the time," recalls Marci. But when she went for her annual
gynecologist visit in late May,that doctor examined her breast and sent her for an ultrasound and mammogram.
Those lead to a biopsy of the lump and lymph nodes, both
of which came back positive. In June, she was diagnosed with Stage 3 breast cancer.
For the rest of the story the link is below.
http://www.dailyfinance.com/2011/10/05/breast-cancers-financial-toll-the-high-cost-of-fighting-for-yo/
FDA Issues Draft Companion Diagnostic Guidance; FDA Generally Will Require Approval or Clearance of Diagnostic at Same Time As Approval of Therapeutic if Safety and Efficacy of Therapeutic Depends on Diagnostic
By Jamie K. Wolszon – July 13, 2011
FDA announced earlier this week the publication of a much-anticipated draft guidance on in vitro companion diagnostic devices. In the draft guidance, FDA stakes out a policy position that if safe and effective use of a therapeutic depends on a diagnostic, then FDA generally will require approval or clearance of the diagnostic at the same time that FDA approves the therapeutic. Companion diagnostics are key to the advancement of personalized medicine. Some well-known companion diagnostics are the tests used to identify patients who will benefit from cancer therapy Herceptin.
FDA outlines two exceptions to this general rule: For new therapeutics, FDA may approve the therapeutic even though the companion diagnostic has not been approved or cleared if the therapeutic product is “intended to treat a serious or life-threatening condition for which no satisfactory alternative treatment exists and the benefits from the use of the therapeutic product with an unapproved or uncleared IVD companion diagnostic device are so pronounced as to outweigh the risks from the lack of an approved or cleared IVD companion diagnostic device.”As for the second exception to the general rule, for therapeutic products that are currently on the market, FDA would be willing to approve a supplement for new labeling even without a cleared or approved companion diagnostic under the following limited circumstances:
(1) The “labeling for an already approved therapeutic product must be revised to address a serious safety issue”; (2) the change made to address this issue requires use of a diagnostic test that is not yet approved or cleared; and (3) “the benefits from the use of the therapeutic product with an unapproved or uncleared IVD companion diagnostic device are so pronounced as to outweigh the risks from the lack of an approved or cleared IVD companion diagnostic device.”The guidance did not provide examples of types of therapeutics or diagnostics that would qualify for these exceptions from the general rule.
The guidance defines IVD companion diagnostic as “an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product.”
FDA provides as an example of an IVD companion diagnostic tests that “identify patients who are most likely to benefit from a particular therapeutic product.” Companion diagnostics also include tests that “identify patients likely to be at increased risk for serious adverse reactions as a result of treatment with a particular therapeutic product” and “monitor response to treatment for the purpose of adjusting treatment (e.g., schedule, dose, discontinuation) to achieve improved safety or effectiveness.”
Companion diagnostics do not include tests intended to provide “information that is useful to the physician regarding the use of a therapeutic product, but that are not a determining factor in the safe and effective use of the product.” For instance, biochemical assays (e.g., serum creatinine tests) used to monitor organ function are not companion diagnostics.
Ideally, according to FDA, a “therapeutic product and its corresponding IVD companion diagnostic device would be developed contemporaneously, with the clinical performance and clinical significance of the IVD companion diagnostic device established using data from the clinical development program of the corresponding therapeutic product.” However, FDA states that it recognizes that this will not always be possible. This expectation that the therapeutic and the companion diagnostic would be developed contemporaneously may be viewed as unrealistic.
The guidance also notes that studies of companion diagnostics generally will be significant risk devices that will require an IDE. Most studies of other IVDs are non-significant risk.
FDA will use a risk-based approach to regulate companion diagnostics. FDA says that in its experience to date, companion diagnostics generally will be Class III devices requiring a PMA, but there could be instances where 510(k) would be sufficient.
The guidance recommends that sponsors consult with both the device center, for a pre-IDE meeting, and the center in charge of regulating the therapeutic component. FDA notes that it is “developing appropriate internal policies and procedures to ensure effective communication among the relevant centers and to promote consistent and efficient product review.” FDA also states that there could be instances where viewed as combination product and thus only one application but did not state what such instances would be.
The guidance also discusses FDA’s view of the need for cross-labeling between the therapeutic and the companion diagnostic.
The guidance has been long-awaited by industry, which has sought guidance in this area – an area that has been marked by ambiguity. Years ago, FDA issued a draft guidance on the topic, which received criticism from industry. FDA stated last year that it would promulgate two guidances to provide clarity that would address issues including when FDA would require simultaneous approval and what data requirements the agency would require.
The comment period for the draft guidance will close within 60 days of issuance, which occurred July 14.
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/07/fda-issues-draft-companion-diagnostic-guidance-fda-generally-will-require-approval-or-clearance-of-d.html
Posted at 06:15 PM in In Vitro Diagnostic Devices, Medical Devices | Permalink