The FDA’s “take” on pre-chemo approval of abiraterone in mCRPC

A new article in Clinical Cancer Research offers us insights into the US Food and Drug Administration’s thinking about the approval of abiraterone acetate for the treatment of chemotherapy-naive patients with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Prostate Cancer Roundtable updates national policy agenda

The Prostate Cancer Roundtable has just announced an update to its national policy agenda — to include a focus on the importance of patient-reported outcomes data affecting quality of life in trials designed with survival as the primary endpoint. … READ MORE …

Are changes in PSA kinetics potentially indicative of metastasis-free survival?

Researchers at Johns Hopkins have provided data to support the hypothesis that, in men being treated with novel, non-hormonal agents for non-metastatic, non-castrate, biochemically recurrent prostate cancer after first-line therapy, changes in PSA kinetics may be indicative of metastasis-free survival. … READ MORE …

Potential surrogate endpoints for prostate cancer-specific survival

There have been several attempts to clearly define surrogate endpoints for prostate cancer-specific survival that could be used to shorten the length of clinical trials investigating the merits of specific forms of treatment for prostate cancer. A new analysis of data from the 1,554-patient RTOG 92-02 trial has further explored two such possibilities. … READ MORE …

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