| Title | Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4. |
| Publication Type | Journal Article |
| Year of Publication | 2026 |
| Authors | Armstrong AJ, Morris MJ, Abida W, Aggarwal RR, Antonarakis ES, Attard G, Beltran H, Bryce A, Carducci MA, Cheng HH, Chen DL, Chi KN, Childs DS, Dahut W, Emmett L, Fizazi K, Gafita A, George DJ, Hermann K, Hofman MS, Hope T, Hussain M, W Kelly K, Kessler E, Kuo PH, Lang J, Liu G, Marshall CH, Morgans AK, McKay RR, Nanus D, Nelson P, Paller C, Reichert ZR, Ryan CJ, A Sartor O, Schöder H, Schwartz LH, Sharifi N, Stadler WM, Stein M, Sternberg CN, Szmulewitz RZ, Tagawa ST, Sokolova AO, Wyatt AW, Yamoah K, Yu EY, Halabi S, Scher HI |
| Corporate Authors | PCWG4 Writing Group |
| Journal | J Clin Oncol |
| Pagination | JCO2502834 |
| Date Published | 2026 Feb 26 |
| ISSN | 1527-7755 |
| Abstract | PURPOSE: The continuous development of new imaging approaches, molecular phenotyping, genetic subtypes, prognosis assessments, and effective therapies across a range of disease states has created a need to redefine terminology and best practices for clinical trial conduct in patients with advanced prostate cancer. METHODS: We convened an international expert committee of diverse working groups, the Prostate Cancer Working Group 4 (PCWG4), between 2016 and 2025. Our objective was to formulate updated criteria based on emerging evidence and clinical trial data in a biomarker context to provide guidance for clinical trial design, eligibility, and end point assessments for patients with advanced prostate cancer. RESULTS: PCWG4 redefines terminology around the disease state and previous therapies in a patient-centric context and terminology focused on androgen pathway modulation. We consider imaging, with a particular focus on positron emission tomography (PET)-defined disease. New recommendations are provided for disease state terminology, defining eligibility criteria, response and delay/prevent end points, intervals for reassessments including imaging, and patient-reported outcome determination. We provide recommendations in a biomarker-based context of use for the intended indication, reflective of patient benefit for specific interventions. We emphasize the need for development of validated PET imaging and molecular and phenotypic criteria as well as trial designs to appropriately risk stratify patients, predict and assess benefit, and measure post-treatment outcomes reliably in a trial framework. CONCLUSION: PCWG4 updates recommendations on patient and tumor characterization, therapy development, and imaging criteria and extends guidance into earlier androgen pathway modulator-naïve/sensitive disease states to reflect an evolving, heterogeneous, and diverse patient population to optimize treatment benefits for all patients. |
| DOI | 10.1200/JCO-25-02834 |
| Alternate Journal | J Clin Oncol |
| PubMed ID | 41744290 |