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Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance

NCT07168616 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 201

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Low Risk Prostate Cancer
  • Clinically Significant Prostate Cancer

Interventions

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)

Sponsors & Collaborators

  • Yeditepe University

    collaborator OTHER

  • Yedikule Training and Research Hospital

    collaborator OTHER

  • Acibadem University

    collaborator OTHER

  • Ankara Yildirim Beyazıt University

    collaborator OTHER

  • University of Gaziantep

    collaborator OTHER

  • Istanbul Training and Research Hospital

    collaborator OTHER_GOV

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    collaborator OTHER

  • Sisli Hamidiye Etfal Training and Research Hospital

    collaborator OTHER

  • Haseki Training and Research Hospital

    collaborator OTHER

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Levent Kabasakal, Prof. MD · Istanbul University - Cerrahpasa

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-15
Completion
2028-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168616 on ClinicalTrials.gov