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Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA

USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for nonmetastatic castration-resistant prostate cancer (nmCRPC).

Nonmetastatic castration-resistant prostate cancer (nmCRPC) is defined as "a rising prostate-specific antigen concentration, despite castrate levels of testosterone with ongoing androgen-deprivation therapy or orchiectomy, and no detectable metastases by conventional imaging".


The length of time from the start of treatment for cancer that a patient is still alive and cancer has not spread to other parts of the body. In a clinical trial, measuring metastasis-free survival is one way to see how well a new treatment works. Also called MFS.

This guidance provides recommendations to sponsors about using metastasis-free survival (MFS) as an endpoint in clinical trials for nonmetastatic castration-resistant prostate cancer (nmCRPC) development programs for drug or biological products regulated by FDA.

The guidance covers recommendations for sponsors on general trial design considerations, imaging considerations, and considerations related to the interpretation of trial results and analyses of MFS.

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