Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Recruiting now
Conditions studied: Low Risk Prostate Cancer, Clinically Significant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT07168616
- Run by
- Istanbul University - Cerrahpasa
- People needed
- 201
- Starts
- 2025-09-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-09-15
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yeditepe University — Istanbul, Turkey, Turkey (Türkiye) (enrolling)
- Bilkent Şehir Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
- Gazi Yaşargil Egitim ve Arastirma Hastanesi — Diyarbakır, Turkey (Türkiye) (enrolling)
- Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi — Gaziantep, Turkey (Türkiye) (enrolling)
- Acibadem University Altunizade Hospital — Istanbul, Turkey (Türkiye) (enrolling)
- Acibadem University Maslak Hospital — Istanbul, Turkey (Türkiye) (enrolling)
- Haseki Eğitim ve Araştırma Hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
- Istanbul University-Cerrahpaşa — Istanbul, Turkey (Türkiye) (enrolling)
- SBÜ Başakşehir Çam Sakura Şehir hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
- Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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