Maximizing Oncology Study Outcomes: Overcoming Enrollment Challenges In A Phase 2 Prostate Cancer Clinical Trial

Background

Prostate cancer (PC) is among the most commonly diagnosed cancers overall, and the most frequently diagnosed cancer in men. The 2018 global estimate of new PC cases exceeded 1.2 million with more than 350,000 deaths worldwide. Over the last decade, new treatments combined with better use of existing therapies in early-stage disease have transformed the PC therapeutic landscape, and new imaging and sequencing technologies have improved screening and detection rates. Nevertheless, many patients present with intermediate or high-risk localized, locally advanced, or metastatic PC and, despite treatment, succumb to the disease. Even though no curative treatment exists for metastatic PC (mPC), the past several years have seen a steady increase in active trials for metastatic, castration-resistant PC (mCRPC) therapies, particularly in the U.S. This has led to increased competition for patients and slower recruitment in mCRPC treatment trials.

Objective

A U.S.-based developer of an investigative therapy for mCRPC engaged Premier Research to increase enrollment in a Phase 2 mCRPC study involving 100 patients at six sites in the United States.

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