FDA committee votes down 5-ARIs for prostate cancer risk reduction – – UrologyTimes

“Although the REDUCE trial demonstrated a risk reduction in a large number of men, the committee chose to focus on a small number of high-grade cancers and determined that this class of drugs is inappropriate for prostate cancer risk reduction, even in the population of men with elevated PSA and previous negative biopsy,” added Dr. Gomella, a co-investigator of the REDUCE trial. “This decision will certainly reduce the enthusiasm for further large-scale, long-term studies of any prostate cancer chemoprevention or risk-reduction strategy.”

via FDA committee votes down 5-ARIs for prostate cancer risk reduction – – UrologyTimes.

This was a disappointing study for me.  Medications such as avodart and proscar have been shown to reduce the risk of prostate cancer.  Early studies revealing a higher percentage of high grade cancers have existed.  These studies were based on biopsy specimens only, which often understage cancer.

Other studies that looked at patients who had removal of the prostate have not revealed a higher incidence of high grade cancers in patients on these medicines.

I will inform patients that the FDA did not approve the indication of prostate cancer reduction for avodart and proscar (finasteride).  I think may patients will still opt for the medication.  Patients with large prostates will also have the benefit of a reduction in BPH symptoms.




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