Prostate Cancer Working Group 4 Unveils Updated Global Standards for Advanced Prostate Cancer Clinical Trials at 2026 ASCO GU Symposium
New Recommendations Address Modern Imaging, Biomarkers, and Evolving Treatment Landscape
The Prostate Cancer Clinical Trials Consortium (PCCTC) today announced the presentation of the Prostate Cancer Working Group 4 (PCWG4) clinical trials guidelines at the 2026 American Society for Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), February 26 - 28, 2026. Building on the widely adopted PCWG3 framework, PCWG4 provides updated standards for enrolling patients, measuring outcomes, and interpreting results in prostate cancer clinical trials.
The new recommendations reflect the evolution in clinical trial design driven by advances in imaging approaches, molecular phenotyping, genetic subtypes, and effective therapies across multiple disease states. An international, multidisciplinary expert committee convened between 2016 and 2025 to develop comprehensive guidance that addresses today's treatment and diagnostic paradigms.
Key Updates Include:
Redefined disease state terminology and prior therapy classifications in a patient-centric context
New imaging-specific radiographic progression-free survival (rPFScriteria, including guidance for PSMA PET/CT imaging
Expanded efficacy assessments incorporating pathology, ctDNA, circulating tumor cells, and PSA declines and changes over time
Recommendations for both androgen pathway modulation sensitive and resistant settings
Specified intervals for imaging, biomarker assessments, and patient-reported outcomes
"PCWG4 represents a critical evolution in how we design and conduct prostate cancer clinical trials in an era of precision medicine. We have updated key terminology for prostate cancer disease states/indications, as our new terminology jettisons the term castration for example, and focuses on a more patient-centric term of androgen pathway modulation," said Dr. Andrew J. Armstrong of Duke University, co-first author of the recommendations. Co-author Michael J. Morris, MD of Memorial Sloan-Kettering Cancer Center added, "The integration of PSMA PET imaging and molecular biomarkers into standardized trial endpoints is a key step forward for prostate cancer research. PCWG4 provides the clinical trials community with the tools needed to more accurately assess treatment effects and identify the patients most likely to benefit from specific therapies.”
The PCWG4 framework emphasizes the need for continued development and validation of PET imaging and molecular criteria to appropriately risk-stratify patients, predict and assess treatment benefit, and measure post-treatment outcomes reliably. The full guidance document, Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4 will be published in the Journal of Clinical Oncology later this month.
Abstract Details:
Title: Trial design and objectives for prostate cancer: Recommendations from the Prostate Cancer Clinical Trials Working Group 4 (PCWG4)
Presenter: Andrew J. Armstrong, MD, MS
Meeting: 2026 ASCO Genitourinary Cancers Symposium
Session Title: Poster Session A: Prostate Cancer
