NCT07168616Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 201 (estimated)
- First submitted
- 5 Sept 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 15 Sept 2026
- Lead sponsor
- Istanbul University - Cerrahpasa
- Diseases
- Prostate cancer
- NCT number
- NCT07168616
What you commit to
- Study type: Observational
- Planned participants: 201
- From 1 Sept 2025 to the primary completion date, 15 Sept 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior prostate cancer treatment or prostate surgery
Other illness
- History of pelvic radiotherapy
- Severe renal impairment
Age
- Life expectancy \<10 years
Other
- High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available)
- MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis
- Inability to comply with follow-up schedule
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bilkent Şehir Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Gazi Yaşargil Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Recruiting |
| Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Recruiting |
| Acibadem University Altunizade Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| İstanbul University-Cerrahpaşa Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Acibadem University Maslak Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Haseki Eğitim ve Araştırma Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Yeditepe University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| SBÜ Başakşehir Çam Sakura Şehir hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.