Study of Delayed vs. Standard PSMA PETCT Imaging to Detect Significant Prostate Cancer in Men Before Biopsy

What this Trial Is About

Researchers are evaluating whether delayed PSMA PET imaging improves the detection of clinically significant prostate cancer compared to standard imaging in men suspected of having newly diagnosed prostate cancer. This prospective, multicenter study focuses on patients who have not yet undergone treatment and aims to fill the gap in evidence about the benefits of delayed imaging timing. The study compares diagnostic accuracy using imaging results and prostate biopsy findings as the standard. All participants undergo two sets of PSMA PETCT scans a standard whole-body scan about 60 minutes after tracer injection and a delayed pelvic-focused scan 2 to 3 hours post-injection. The delayed images use the previously acquired CT data for correction. Each patient acts as their own control, allowing for direct comparison of the two imaging approaches. Biopsy results serve as the reference to confirm the presence and severity of cancer. During the study, patients will have imaging scans followed by prostate biopsies to confirm diagnosis. Researchers will analyze the imaging results to compare their accuracy in detecting clinically significant prostate cancer. Outcomes include measures like the area under the curve AUC for imaging accuracy, biopsy avoidance potential, changes in clinical management, and subgroup analyses by PSA levels. An independent monitor oversees data quality and safety throughout the study, which will continue until 2028.

Delayed PSMA PET/CT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biopsy-Naïve Men With Suspected Prostate Cancer