RecruitingNCT07168616

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


Sponsor

Istanbul University - Cerrahpasa

Enrollment

201 participants

Start Date

Sep 1, 2025

Study Type

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a specialized type of scan called PSMA PET/CT — which highlights prostate cancer cells very precisely — can help doctors identify which men with low-risk prostate cancer are truly safe to monitor with active surveillance (watchful waiting without immediate treatment) instead of surgery or radiation. **You may be eligible if...** - You are a man with low-risk prostate cancer confirmed by biopsy (grade group 1) - Your PSA level is 10 ng/mL or below - Your cancer appears to be early-stage (up to T2a on imaging) - You have no more than 3 positive biopsy cores - You have a life expectancy of at least 10 years - You have had an MRI and prostate biopsy recently **You may NOT be eligible if...** - Your cancer is intermediate or high risk - You have already had any prostate cancer treatment or surgery - Imaging shows cancer has spread outside the prostate - You have had a prior PSMA PET scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTGa-68 PSMA11 PET/CT

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


Locations(10)

Yeditepe University

Istanbul, Turkey, Turkey (Türkiye)

Bilkent Şehir Hastanesi

Ankara, Turkey (Türkiye)

Gazi Yaşargil Egitim ve Arastirma Hastanesi

Diyarbakır, Turkey (Türkiye)

Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi

Gaziantep, Turkey (Türkiye)

Acibadem University Altunizade Hospital

Istanbul, Turkey (Türkiye)

Acibadem University Maslak Hospital

Istanbul, Turkey (Türkiye)

Haseki Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

SBÜ Başakşehir Çam Sakura Şehir hastanesi

Istanbul, Turkey (Türkiye)

Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT07168616


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