Leonard G. Gomella, MD, from the Thomas Jefferson University Hospital, describes the identification of appropriate surrogate endpoints for the evaluation of new therapies for patients with metastatic castration-resistant prostate cancer.
Leonard G. Gomella, MD, professor and chair of the Department of Urology at Thomas Jefferson University Hospital, describes the need to identify appropriate surrogate endpoints for the evaluation of new treatments and combination strategies in metastatic castration-resistant prostate cancer (mCRPC).
Some of the challenges facing mCRPC researchers revolve around the currently accepted endpoints used in clinical trials, Gomella notes. In some cases, PSA is an effective endpoint. However, newer endpoints, such as radiographic progression-free survival and RECIST criteria, may also be considered and should be explored more thoroughly, Gomella believes.
In general, overall survival is still the major endpoint needed for regulatory approval of new medications in mCRPC. In addition to OS, quality of life measurements are an important endpoint to consider. As more targeted and novel agents are developed, the focus on identifying and validating surrogate endpoints will continue to increase, Gomella believes.