National Cancer Institute's Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design...

Area of Science:

• Urology
• Oncology
• Radiology

Background:

• Biochemical recurrence (BCR) of prostate cancer (PCa) after definitive treatment is a growing research focus.
• Current clinical trials for PCa primarily target metastatic disease based on conventional imaging.
• Existing trial principles may not be optimal for future BCR studies.

Purpose of the Study:

• To establish principles for future clinical trials in BCR of PCa.
• To address nomenclature, data capture, imaging, and trial design for BCR.
• To optimize trial strategies for ultrasensitive imaging-emergent BCR.

Main Methods:

• A National Cancer Institute (NCI) Working Group (WG) convened to discuss BCR clinical trials.
• Key areas included nomenclature, baseline criteria, imaging, high-risk populations, therapy requirements, quality of life, and endpoints.
• Discussions aimed to inform future trial development in BCR.

Main Results:

• The NCI BCR WG defined "prostate-specific membrane antigen (PSMA)+BCR" for PCa recurrence detectable by PSMA PET imaging.
• High-risk BCR was suggested with a prostate-specific antigen doubling time of ≤6 months.
• Recommendations were made for baseline data, imaging, and consideration of novel endpoints and quality-of-life metrics.

Conclusions:

• Future BCR trials should be designed for this distinct disease space, separate from conventionally defined metastatic disease.
• The NCI BCR WG advocates for deintensified treatment strategies in future trials to minimize toxicity.
• These recommendations aim to improve clinical trial design and patient outcomes in BCR.