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# Prostate Cancer Trial Endpoint Guidance
- URL: https://www.fdaweb.com/prostate-cancer-trial-endpoint-guidance/
- Published: 2018-11-13T12:00:00.000Z
- Updated: 2026-09-15T00:44:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142809

FDA has issued a draft guidance, *Nonmetastatic, Castration-Resistant Prostate Cancer; Considerations for Metastasis-Free Survival Endpoint in Clinical Trials*, for drug or biological product development programs regulated by CDER and CBER. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM625703.pdf?ref=fdaweb.com) says issues involving metastasis-free survival were discussed at a 2011 Oncologic Drugs Advisory Committee meeting where committee members acknowledged that endpoints that can be measured earlier in the course of disease or in the time from randomization to distant radiographic disease or death would be useful to assess the treatment effect of products in patients with nonmetastatic, castration-resistant prostate cancer.

The draft covers general trial design considerations, imaging considerations, considerations related to interpretation of trial results, and considerations related to analysis of metastasis-free survival.