The Prostate Cancer Clinical Trials Working Group (PCWG) recommendations have guided the design and interpretation of prostate cancer trials for more than two decades. Rapid advances in molecular diagnostics, imaging, and systemic therapies have substantially altered the clinical landscape, prompting the recent update to the framework. PCWG4 introduces a shift towards patient-centred terminology and end points, incorporating molecular and imaging biomarkers for trial eligibility and response assessment. The updated guidance also provides recommendations for integrating Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography into clinical trial frameworks and proposes revised definitions of radiographic progression. PCWG4 emphasises the use of patient-reported outcome measures and introduces the concept of "no longer clinically benefitting" to guide treatment continuation beyond conventional progression end points. This recap summarises key updates in PCWG4 and highlights their implications for contemporary prostate cancer clinical trial design and interpretation.
European urology focus. 2026 Jun 19 [Epub ahead of print]
Aravind S Ravi Kumar, Aaron R Hansen
Integrated Theranostics Centre, Department of Radiology, Princess Alexandra Hospital, Brisbane, Australia; School of Medicine, University of Queensland, Queensland, Australia. Electronic address: ., School of Medicine, University of Queensland, Queensland, Australia; Integrated Theranostics Centre, Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.