PET Scan Using Flotufolastat F-18 Posluma to Detect Early Recurrence of Prostate Cancer After Surgery

What this Trial Is About

Researchers are evaluating the use of flotufolastat F-18, known as Posluma, a radioactive agent used with PET imaging, to detect prostate cancer in men who have very low levels of Prostate-Specific Antigen PSA after previous radical prostatectomy surgery. This study focuses on early PSA recurrence in prostate cancer patients and aims to assess how well the 18F-rhPSMA-7.3 PET scan detects cancer compared to other methods. Participants will receive a PET scan using 18F-rhPSMA-7.3 Posluma to identify prostate cancer recurrence. If the first scan does not detect cancer but PSA levels rise by more than 0.1 ngml, the PET scan will be repeated. This study uses a single-arm design where all participants receive the flotufolastat PET scan, which is FDA approved for detecting PSMA-positive prostate cancer lesions in men suspected of having metastasis or recurrence. During the study, participants will undergo PET scans and their results will be compared with biopsy findings, other imaging methods, and treatment responses over a 24-month period. Researchers will monitor adverse events within 24 hours after the scan. The main measure is the cancer detection rate at 24 months. The study is open-label and does not involve masking, and participants will be followed for up to two years to evaluate the scans effectiveness in detecting early prostate cancer recurrence.

PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence