Opko Health Inc (OPK)

[WiseFool]

Dr. Dipen Parekh On Opko 4Kscore “As of today, it is the most accurate model in the entire world to predict high-grade cancer”

Prostate cancer tests, treatments an imperfect science

By Julie Landry Laviolette – Special To The Miami Herald
03/20/2015 8:00 AM 03/20/2015 12:00 PM

Screening for prostate cancer is not an exact science.

“There is not a consensus in the medical community about when or how is best,” said Dr. Rosendo Collazo, a primary care doctor with Baptist Health Primary Care in Miami. “It really depends on the physician having a sense of the patient’s risk factors.”

Men 50 and older, those with a family history, and African-American men have a higher risk.

The most common screening test, the Prostate-Specific Antigen, or PSA, is a blood test that measures a protein sometimes found in high amounts in men with prostate cancer.

“The problem with the PSA is that it’s not an accurate predictor. There isn’t a number result that tells you that you have or don’t have cancer,” Collazo said. Traditionally, the norm was set at 0-4, and anyone above 4 was referred for biopsy. But the PSA test is not reliable.

“We know there are people with prostate cancer who have PSAs below 4, and there are people without prostate cancer who have PSAs of 6 or 7,” Collazo said.

One reason is that PSA levels can be influenced by factors other than prostate cancer. It can be elevated in the bloodstream by an infection in the prostate, or lowered by medications such as aspirin or statins.

Typically patients with a high PSA level undergo a rectal exam and are referred for a biopsy. If prostate cancer is found, the patient is typically treated with surgery, radiation or hormone therapy.

But that thinking is changing.

The complicating factor is that not all prostate cancers are equal, said Dr. Akshay Bhandari, co-chief of the Columbia University Division of Urology at Mount Sinai Medical Center in Miami Beach. There are various grades of prostate cancer, from least to most aggressive. Low-grade cancers can be slow-growing and not affect quality of life for years, if at all, Bhandari said.

Dr. Dipen Parekh, chairman of the Department of Urology at the University of Miami Miller School of Medicine agrees. “But in the United States, finding cancer equates to treating cancer, even these low-grade cancers that for the most part do not harm someone,” he said.

The treatment may cause more damage to the quality of life of the patient, without increasing his survival rate, Parekh said.

Prostate cancer treatment, as much as it has advanced, is a rough ride, Collazo said. Impotence and urinary incontinence can result. “Before you go to those lengths, you’re going to want to make sure that the prostate cancer is going to impact your health,” he said.

If low-grade cancer is found, it can be monitored through repeat biopsies and imaging such as MRIs, PSAs and rectal exams, Parekh said. “If the cancer continues to grow, you treat it, and if not, you can very safely watch it for a long period of time,” he said. The University of Miami has a survivorship program to help patients cope.

Now doctors are trying to reduce unnecessary biopsies and overtreatment through more comprehensive screening methods. Parekh was a lead physician on the clinical trial of the 4Kscore, a screening method that became available last March. It is typically used after an elevated PSA has been found and a biopsy is recommended.

The 4Kscore looks at the measurement of four proteins in the blood, the results of the prostate exam, patient age and whether or not the patient has had a prior biopsy, Parekh said. “The result is a risk score that predicts the likelihood of aggressive prostate cancers,” he said.

“The ideal time to do the 4Kscore is before a biopsy. So if the score is high, your chances of finding an aggressive cancer are higher, and if the score is low, the chance of finding an aggressive cancer is lower, and you may defer the biopsy,” Parekh said.

The 4Kscore is about 82 percent accurate, he said. “As of today, it is the most accurate model in the entire world to predict high-grade cancer,” Parekh said.

The test is not covered by insurance. The out-of-pocket cost is $395-$450.

“It’s a relatively new test, but very soon, I think this test should be, and must be adopted by primary care physicians,” Parekh said.

Doctors say the best approach to prostate cancer screening is to evaluate on a case-by-case basis.

“Prostate cancer screening has come under a lot of flak because PSA testing is not the greatest test,” Bhandari said. “But we don’t want to throw out the baby with the bath water. Just because it’s not perfect, doesn’t mean it needs to be abandoned. I think for a certain age group, there is still a lot of benefit to screening.”

For example, a recent study that showed testicular cancer patients have a higher probability of getting prostate cancer is significant because it helps pinpoint those at risk, he said.

“More research needs to be done, but what we’re trying to do is isolate certain high-risk groups that would benefit from screening,” Bhandari said.

The American Urological Association recommends that men ages 55 to 69 with no family history of prostate cancer and no symptoms talk to their doctors about the risks and benefits of screening.

“But if you have a healthy 75-year-old who goes to the gym, who you think has a good chance of living the next 10 years, it’s not inappropriate to screen them,” Bhandari said.

The most common symptom of prostate cancer is nothing, Collazo said. But there are symptoms that could be caused by cancer or other issues that should be checked out. They are a sudden change in urinary flow, discomfort in urination, interrupted stream and changes in frequency — urinary tract infection symptoms that men don’t typically get.

“These are triggers that should be followed up on with a PSA, but those are the exception, they are not the norm,” Collazo said.