Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
Istanbul University - Cerrahpasa
201 participants
Sep 1, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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
Exclusion Criteria7
- High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available)
- Prior prostate cancer treatment or prostate surgery
- MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis
- History of pelvic radiotherapy
- Life expectancy \<10 years
- Severe renal impairment
- Inability to comply with follow-up schedule
Interventions
delayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)
Locations(10)
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NCT07168616