Emerging Endpoints: Metastasis-Free Survival
Nonmetastatic, castration-resistant prostate cancer is a frequently recurrent form of prostate cancer. The treatment-resistant nature means continuous androgen-deprivation therapy and a resultant decrease in the quality of life of the patient. It also makes for a prolonged assessment period for treatments, which makes the overall survival rate an impractical endpoint. Thus, nonmetastatic, castration-resistant prostate cancer is a textbook example of the need for non-traditional endpoints such as metastasis-free survival.
When designing a trial with metastasis-free survival as an endpoint, it is important to consider the following:
- Sponsors must clearly establish MFS definitions prior to trial.
- This definition must exclude local progression events.
- Because of the long-term nature of the study, protocols must specify in advance how they plan to mitigate attrition.
- Mitigation plans should account for patients dropping out over PSA anxiety.
- Testing should exclude patients who might benefit from radiotherapy.
- Trials must define castration-resistant disease.
New FDA guidelines underscore the need to work with a biostatistical CRO specializing in data analysis. This can aid your trials from the design of protocols all the way through to the approval process at Phase 3.
Our next blog on the new FDA advisory will be about using minimal residual disease as an endpoint in your trials.
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