FDA Proposes Metastasis-Free Survival Endpoint in Prostate Cancer Trials

The FDA issued draft guidance for clinical trial sponsors of treatments for a rare form of prostate cancer — nonmestastatic, castration-resistant prostate cancer (nmCRPC) — and said it will consider metastasis-free survival as an endpoint.

The illness is defined by rising levels of prostate-specific antigens even after testosterone levels have been reduced. The disease can take years to run its course — and that has made it difficult for sponsors to use overall survival rates as an endpoint in clinical trials.

For years, sponsors, researchers and other experts have urged the FDA to consider metastasis-free survival a primary endpoint for trials aimed at nmCRPC. The agency now says it’s open to doing so but wants to be sure that sponsors map out their plans carefully.