Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4

The Prostate Cancer Working Group 4 (PCWG4) has published updated consensus recommendations for clinical trial design and endpoint selection in prostate cancer, appearing in the Journal of Clinical Oncology. Building on the widely adopted PCWG3 framework from 2016, the new guidelines reflect the rapidly evolving treatment landscape that now includes PARP inhibitors, radioligand therapies, and novel hormonal agents. These recommendations standardize how eligibility criteria, response assessments, and trial objectives should be defined across the disease spectrum, from hormone-sensitive to metastatic castration-resistant prostate cancer. The PCWG series has historically been one of the most influential forces shaping prostate cancer drug development, and PCWG4 is expected to serve as the reference framework for regulatory submissions and academic trials for years to come.