Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4.
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Armstrong Andrew J, Morris Michael J, Abida Wassim, Aggarwal Rahul R, Antonarakis Emmanuel S, Attard Gerhardt, Beltran Himisha, Bryce Alan, Carducci Michael A, Cheng Heather H, Chen Delphine L, Chi Kim N, Childs Daniel S, Dahut William, Emmett Louise, Fizazi Karim, Gafita Andrei, George Daniel J, Hermann Ken, Hofman Michael S, Hope Thomas, Hussain Maha, Kelly W Kevin, Kessler Elizabeth, Kuo Phillip H, Lang Joshua, Liu Glenn, Marshall Catherine H, Morgans Alicia K, McKay Rana R, Nanus David, Nelson Peter, Paller Channing, Reichert Zachery R, Ryan Charles J, Sartor A Oliver, Schöder Heiko, Schwartz Lawrence H, Sharifi Nima, Stadler Walter M, Stein Mark, Sternberg Cora N, Szmulewitz Russell Z, Tagawa Scott T, Sokolova Alexandra O, Wyatt Alex W, Yamoah Kosj, Yu Evan Y, Halabi Susan, Scher Howard I, PCWG4 Writing Group
Аннотация
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.