National Cancer Institute’s Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design Considerations
Abstract
Purpose: Biochemically recurrent prostate cancer (BCR) after definitive surgery and/or radiation (including salvage strategies) is a burgeoning area of clinical research inspired by ultrasensitive next-generation imaging. Most phase 3 trials in prostate cancer (PCa) have focused on metastatic disease, defined by conventional imaging (CI). 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 “PSMA+BCR” to identify the emerging concept of recurrent PCa identifiable only on PSMA PET, overlapping with BCR and distinct from metastatic hormone-sensitive PCa as traditionally defined by CI. The WG suggested defining high-risk BCR with a PSA doubling time ≤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 endpoints and quality-of-life metrics in this disease space. Conclusions:…
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.