Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET/CT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.
• mpMRI performed within 3 months prior to enrollment
• Systematic or MRI-targeted prostate biopsy performed
• Biopsy-confirmed ISUP Grade 1 low-risk PCa
• Prostate biopsy report specifying tumor localization and number of positive cores
• Meets AS criteria: ISUP 1, PSA ≤10 ng/mL, PSAd \>0.15 ng/mL², clinical stage cT1c-T2a, ≤3 positive cores
• Life expectancy ≥10 years
• No prior PSMA PET imaging
• No evidence of extra-prostatic disease on mpMRI
• Signed informed consent for study procedures