A new clinical trial being run by some of the investigators who originally coordinated the Prostate Cancer Prevention Trial is investigating whether a brief period of finasteride therapy (“finasteride challenge”) can help to distinuish between patients at serious risk for prostate cancer and those who don’t even need a biopsy.
The so-called “finasteride challenge” study will enroll about 500 patients. It started enrolling patients last month and is expected to run through to 2015.
The fundamental idea behind this study is that 3 months of treatment with finasteride (a 5α-reductase inhibitor or 5-ARI) may improve the clinical significance of PSA data in men who would normally be scheduled for immediate prostate biopsy.
It is well known from the Prostate Cancer Prevention Trial that treatment with finasteride will lower the PSA levels of many men with initially elevated PSA values. The investigators plan to enroll men with a 20 to 60 percent risk for prostate cancer based on evaluation of their risk using the Prostate Cancer Calculator; all such men must have been scheduled for and plan to have a prostate biopsy. However, rather than receiving an immediate biopsy, the men will first receive 3 months of finasteride at a dose of 5 mg/day. At the end of the 3-month period, they will then be biopsied.
The researchers believe that it may be possible to show that the men who have a significant decrease in their PSA levels are much more likely to have a negative biopsy result, which would offer a simple and convenient way to eliminate the need for prostate biopsies in tens of thousands of American men every year.
Additional commentary on this study (with quotes from the first man to enroll in the study) is available on the MySanAntonio web site.