NCT07168616

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 201 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prostate cancer is the most common malignancy in men and demonstrates heterogeneous clinical behavior. While many low-risk patients have indolent disease, a subset harbors clinically significant prostate cancer (csPCa) requiring early intervention. Active Surveillance (AS) is widely used to avoid overtreatment; however, current selection criteria-PSA, DRE, biopsy Gleason score, number of positive cores, PSA density, and mpMRI-lack sufficient predictive accuracy. Studies indicate that up to 30% of patients classified as low-risk by biopsy are found to have higher-grade disease at radical prostatectomy. The Istanbul PSMA PET/CT Criteria (IPPC) were developed by a multidisciplinary expert panel in Turkey to classify intraprostatic lesions on delayed (120-minute) Ga-68 PSMA PET/CT imaging into three risk categories: * IPPC 1 No or homogeneous low uptake - safe for monitoring. * IPPC 2: Indeterminate uptake - AS with close follow-up. * IPPC 3: Focal, lentiform, high SUVmax ≥12 uptake in peripheral zone - definitive treatment recommended. This study will evaluate the diagnostic performance of IPPC compared to standard mpMRI and biopsy findings, using radical prostatectomy pathology or long-term clinical follow-up as the reference standard.

Conditions

• Low Risk Prostate Cancer
• Clinically Significant Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ga-68 PSMA11 PET/CT	delayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-15
• Completion: 2028-06-01
• First posted: 2025-09-11
• Last updated: 2025-09-15

Locations

10 sites across 1 country: Turkey (Türkiye)