Guide on Nonmetastatic, Castration-Resistant Prostate Cancer

Federal Register notice: FDA has made available a draft guidance entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.” This form of cancer is defined by rising prostate-specific antigen (PSA) despite castrate levels of testosterone and no radiographic evidence of distant metastatic disease. FDA says that despite earlier detection of localized prostate cancer and advances in surgical and radiation techniques, many patients will continue to have rising PSA after local therapy (e.g., surgery, radiation) for recurrent disease and subsequent androgen deprivation therapy. The agency believes prolonged assessment periods (patients receiving multiple therapies) with low event rates may make the use of overall survival impractical as a primary endpoint to support approval of products in this disease setting. To view the notice, click here.