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# Guide on Prostate Cancer Clinical Endpoints
- URL: https://www.fdaweb.com/guide-on-prostate-cancer-clinical-endpoints/
- Published: 2021-08-06T12:00:00.000Z
- Updated: 2026-09-14T17:09:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149884

FDA has issued a [final guidance](https://www.fda.gov/media/117792/download?ref=fdaweb.com) entitled *Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials*. The document provides recommendations on using such endpoints in clinical trials for nonmetastatic castration-resistant prostate cancer product development programs. For example, it recommends that:

- Sponsors should establish the definition of metastasis-free survival before initiating the trial, and the definition should exclude local progression events (e.g., progression in pelvic lymph nodes below the aortic bifurcation).
- Sponsors should consider stratification of randomization by prior local definitive therapy(e.g., surgery, radiation), or lack of prior definitive therapy, and by *prostate*\-specific antigen (PSA) doubling time (with timing and number of PSA measurements specified before trial initiation).
- The protocol should prespecify procedures to reduce attrition in both treatment arms caused by patients who withdraw from the trial because of concern about persistently rising PSA values.
- A superiority trial design should be used.
- Trials should exclude patients who could benefit from local therapy (e.g., surgery or radiation) to the prostate or pelvis. Such patients could be enrolled after completing local therapy if their PSA continues rising and meets trial entry criteria.