Biotech Values

[DewDiligence]

Squalamine trial in prostate cancer includes both neo-adjuvant and adjuvant treatment:

[There’s been some confusion on the Yahoo board about this trial; for instance, ‘ridge_runner’ said in message #48329 that the trial’s “blind” would be broken following analysis in the pathology lab, but the trial is not even blinded. Therefore, I thought it would help to post the summary from the trial’s overseer, the University of Chicago. (U. of C. is conducting this trial under a grant from the U.S. Department of Defense: #msg-1886712.)

This is an unusual trial design in that Squalamine is given to *half* the patients before surgery (called “neo-adjuvant” treatment) and to *all* of the patients post-surgery (called “adjuvant” treatment). All patients also receive Lupron anti-androgen therapy before and after surgery.

The only way one could blind patients to whether they were or weren’t receiving pre-surgery Squalamine would be to give the non-Squalamine patients a sham infusion, but that isn’t done in this trial. Perhaps the trial’s internal review board thought that a prostatectomy, which all patients in this trial receive, was enough poking.]

http://www.uchospitals.edu/clinical-trials/11345b.php

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Anti-Angiogenesis Therapy for Prostate Cancer: A Research Study for Men with Prostate Cancer Undergoing Radical Prostatectomy

Study Summary

This research project is designed for men diagnosed with a form of prostate cancer that is likely to recur after surgery. When diagnosed early, before it has spread from the prostate to other parts of the body (a process known as metastasis), prostate cancer is often curable with surgery (an operation known as a radical prostatectomy). Sometimes, however, prostate cancer can recur after surgery, even though there was no evidence of metastasis at the time of the operation.

Certain characteristics of prostate cancer have been identified that increase the likelihood of this happening. These include a PSA (a blood test used to diagnoses prostate cancer) greater than 10ng/ml, a large hard tumor felt during your rectal examination, and aggressive-appearing cancer cells (Gleason grade 4 or greater) on your biopsy specimen. You are potentially eligible to enter this study if your cancer has at least one of these characteristics.

This study will evaluate whether giving an experimental anti-angiogenesis drug (designed to block the supply of blood and nutrition to cancer cells) before radical prostatectomy (removal of the prostate gland) will improve the cure rates of surgery and induce anti-cancer changes in the prostate. In addition, the safety of giving anti-angiogenesis therapy before surgery will be evaluated. This trial is for men who are considering surgical treatment for their prostate cancer. Please note, anti-angiogenesis therapy for men with prostate cancer is experimental.

Prior to surgery, all men will be treated with six weeks of androgen ablation therapy (medicine that stops the production of the male sex hormones, such as testosterone). Half of the men will randomly be assigned (as in a flip of a coin) to also receive Squalamine, an experimental anti-angiogenic drug derived from shark liver, during these six weeks. All of the patients will then undergo prostate surgery (radical prostatectomy). One week after surgery, all men will receive the combined androgen ablation and anti-angiogenesis drug therapy for six weeks.

Participation Details

• Must have biopsy-proven prostate cancer with at least one of the characteristics associated with recurrence after surgery [a prostate screening (PSA) blood test greater than 10ng/ml, a hard palpable tumor felt during rectal examination, and Gleason grade 4 (a method used to characterize prostate tumors) or greater pathology]
• Must be free of metastases or other cancers
• Must be healthy enough to undergo surgery
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