Study of Serial PSMA PET Scans to Monitor Treatment Response in Newly Diagnosed Clinically Significant Prostate Cancer in Men

What this Trial Is About

Researchers are evaluating the usefulness of serial PSMA PET scans to monitor therapy in men newly diagnosed with clinically significant prostate cancer, defined by a Gleason score of 7 or higher. This prospective, multicenter, observational study aims to improve treatment response assessment, which currently relies on PSA changes and conventional imaging that may lack early sensitivity. The study includes patients scheduled for curative-intent or systemic therapy such as radiotherapy, androgen deprivation therapy ADT, chemotherapy, or combinations thereof. Participants undergo a baseline PSMA PETCT scan before starting any treatment. A follow-up PSMA PETCT scan is performed either when PSA levels indicate recurrence or within 12 to 24 months after completing treatment if no recurrence occurs. The same radiotracer and scanner are used for consistency. Researchers will analyze changes in maximum standardized uptake value SUVmax and the number of PSMA-avid lesions, correlating these with treatment response categories defined by PSA kinetics, conventional imaging, and clinical outcomes. During the study, patients receive standard treatments determined by their physicians. Researchers collect imaging data centrally and analyze it with standardized software, including independent lesion counts by two nuclear medicine physicians. Outcome measures include changes in SUVmax and lesion count, treatment strategy changes, agreement between PSMA PET and PSA responses, and associations with progression-free survival and time to castration resistance. The study follows participants for up to two years, assessing safety, adherence to follow-up imaging, and clinical outcomes.

Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer