#3: Faster Clinical Trials

In order for the FDA to approve a new therapy, an improvement in length or quality of life due to the therapy must first be demonstrated in clinical trials. The “overall survival” (OS) endpoint, which measures the length of time from randomization to death from any cause, is the gold standard for measuring the impact of a treatment on length of life. In localized prostate cancer, reaching an OS endpoint can require 10-15 years — a prohibitive timeframe for pharmaceutical companies. This fact has translated into only limited improvements being made in the treatment of early, aggressive prostate cancer in the last decade.

PCF identified this issue as a critical unmet need, and in 2012, supported the establishment of a working group called ICECaP (Intermediate Clinical Endpoints of Cancer of the Prostate), an international collaborative initiative to undertake the arduous task of identifying an intermediate clinical trial endpoint that can accurately predict overall survival but could be obtained much earlier in the course of the disease.

Establishment of an intermediate “surrogate” endpoint would hasten clinical trials and regulatory approvals for new therapies for early prostate cancer patients.

Led by Dr. Christopher Sweeney of Dana-Farber Cancer Institute, the ICECaP group found that measuring metastasis-free survival (MFS) — the length of time before the cancer spread beyond the Prostate Gland — was a strong predictor of OS. Using MFS as an endpoint instead of OS could enable more clinical trials to be carried out in a shorter period of time.

This news is of particular importance to men whose cancer was confined to the prostate gland and were treated with radiation or surgery, but are considered to be at medium or high risk of relapse because of the aggressiveness of other pathological features of their cancer.

“The discovery of this surrogate endpoint has enormous implications for patients with prostate cancer. Reducing the time needed to conduct clinical trials will accelerate the development of new treatments that can be administered at the earliest stage possible, when the cancer might still be curable,” said Howard Soule, PCF’s Chief Science Officer.

For more detail on ICECaP check out:
https://www.pcf.org/news/statistical-shortcut-speed-evaluation-prostate-cancer-drugs/

 

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