Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Recruiting · NCT07168616 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istanbul University - Cerrahpasa
View the official record on ClinicalTrials.gov →Interventions studied
Ga-68 PSMA11 PET/CT
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
10 locations listed.
- 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)
- Yeditepe University - Istanbul, Turkey, Turkey (Türkiye)