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

Recruitingn/aAges 18 Years - anyMaleIstanbul University - Cerrahpasa
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Ga-68 PSMA11 PET/CT
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Where

10 sites
Yeditepe University
Istanbul, 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)

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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