National Cancer Institute's Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design Considerations
Year: 2025
Type: article
Abstract: PURPOSE: Biochemical recurrence (BCR) of prostate cancer (PCa) after definitive surgery and/or radiation (including salvage strategies) is a burgeoning area of clinical research inspired by ultrasensitive next-generation imaging. Most phase III trials in PCa have focused on metastatic disease, defined by conventional imaging. Despite the emergence of new imaging, clinical trial principles from metastatic studies will not optimize future BCR trials. METHODS: A Working Group convened at the National Cancer Institute on November 13, 2024 (NCI BCR WG). Key areas of discussion included nomenclature, baseline criteria for data capture, imaging considerations, delineation of high-risk populations to be targeted for trial development, requirements of metastasis-directed therapy (MDT) or hormonal therapy, quality-of-life considerations, and potential study end points. RESULTS: The NCI BCR WG defined the novel term "prostate-specific membrane antigen (PSMA)+BCR" to identify the emerging concept of recurrent PCa identifiable only on PSMA positron emission tomography (PET), overlapping with BCR and distinct from metastatic hormone-sensitive PCa as traditionally defined by conventional imaging. The WG suggested defining high-risk BCR with a prostate-specific antigen doubling time of ≤6 months, regardless of PET findings. The WG provided recommendations for baseline data capture and imaging requirements. Neither systemic therapy nor MDT were considered mandatory for control arms. The WG also discussed novel end points and quality-of-life metrics in this disease space. CONCLUSION: These discussions should inform future clinical BCR trials in this distinct disease space relative to metastatic disease defined by conventional imaging. The NCI BCR WG strongly advocates that future trials explore deintensification of treatment to minimize toxicity in this relatively indolent disease state.
Source: Journal of Clinical Oncology
DOI: 10.1200/jco-25-01693
Authors: David J. Einstein, Melissa L. Abel, Jeanny B. Aragon-Ching, Philip M. Arlen, Karen A. Autio, Marijo Bilusic, Michael A. Carducci, Peter L. Choyke, Deborah E. Citrin, William D. Figg, Julie N. Graff, James L. Gulley, Susan Halabi, Fatima Karzai, Liza Lindenberg, Mark C. Markowski, Catherine H. Marshall, Douglas G. McNeel, Esther Mena, Helen Moon, Russell K. Pachynski, Channing J. Paller, Krishnan R. Patel, Edwin M. Posadas, Kenneth J. Pienta, Meredith M. Regan, Laura A. Sena, Charlotte S. Walmsley, Xiao X. Wei, Evan Y. Yu, Phuoc T. Tran, Ravi A. Madan
Institutions: Beth Israel Deaconess Medical Center, National Institutes of Health, National Cancer Institute, Center for Cancer Research, Inova Fairfax Hospital, Memorial Sloan Kettering Cancer Center, University of Miami, Johns Hopkins University, Johns Hopkins Medicine, Portland VA Medical Center, Duke University, Duke Medical Center, University of Wisconsin–Madison, Kaiser Permanente Riverside Medical Center, Washington University in St. Louis, Cedars-Sinai Medical Center, Dana-Farber Cancer Institute, Fred Hutch Cancer Center, University of Maryland, Baltimore
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: National Cancer Institute
Award: G135985217
OpenAlex ID: W4415484355