What this Trial Is About

Researchers are evaluating a new PET imaging agent called [18F]AlF-PSMA-N5 in men with prostate cancer to see how it spreads in the body and how well it helps diagnose, detect recurrence, and find metastases. This early phase 1 study compares this new agent with an existing PET/CT agent called [18F]F-DCFPyL to understand differences in detection and accuracy for prostate cancer. The study focuses on measuring how much the tumor takes up the imaging agents using a value called SUVmax and compares sensitivity, specificity, and lesion detection between the two agents. Participants receive a single intravenous injection of [18F]AlF-PSMA-N5 and undergo PET/CT imaging within a specified timeframe. They also receive a single injection of [18F]F-DCFPyL followed by PET/CT imaging for comparison. Both imaging tests are done within two weeks of each other. The study tracks the number, accuracy, and distribution of lesions identified in different organs using these imaging agents. During the study, patients provide complete MRI images and clinical data such as PSA levels and Gleason grade. Pathological examination through surgery or biopsy is performed to confirm prostate cancer before or after treatment. Researchers measure the standardized uptake value (SUV) at 30 days as the primary outcome. Safety and diagnostic efficacy are monitored, and informed consent is obtained. Participants are men aged 18 to 90 years with prostate cancer or suspected recurrence, willing to undergo the required imaging and biopsies.

Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis