Using PSMA PET/CT imaging to help choose which men with low-risk prostate cancer can enter active surveillance
Prospective Evaluation of Istanbul PSMA PET/CT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer
The team will test whether delayed Ga-68 PSMA PET/CT scans using the Istanbul PSMA PET/CT Criteria can help decide which men with biopsy-confirmed low-risk prostate cancer can safely choose active surveillance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 201 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 10 sites (Istanbul, Turkey and 9 other locations) |
| Trial ID | NCT07168616 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective diagnostic accuracy study that adds a delayed (120-minute) Ga-68 PSMA PET/CT scan into the diagnostic pathway for men with biopsy-confirmed ISUP Grade 1 prostate cancer. Images will be classified using the Istanbul PSMA PET/CT Criteria (IPPC) into three risk categories (no/low uptake, indeterminate, focal high uptake) and compared to standard mpMRI and biopsy findings. The study will use radical prostatectomy pathology or long-term clinical follow-up as the reference standard for clinically significant disease. The goal is to refine patient selection for active surveillance to reduce unnecessary interventions while avoiding missed higher-grade cancers.
Who should consider this trial
Good fit: Men with biopsy-confirmed ISUP Grade 1 (low-risk) prostate cancer who meet active surveillance criteria (for example PSA ≤10 ng/mL, clinical stage cT1c–T2a, ≤3 positive cores, life expectancy ≥10 years), have a recent mpMRI, and no prior PSMA PET are ideal candidates.
Not a fit: Men with higher-risk or unfavorable histologies, prior prostate cancer treatment, MRI evidence of extracapsular extension or metastasis, severe comorbidity, or life expectancy under 10 years are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could better identify men who can safely avoid immediate treatment, reducing unnecessary biopsies and MRIs and lowering overtreatment rates.
How similar studies have performed: PSMA PET/CT is well established for prostate cancer staging and detecting clinically significant disease, but using delayed Ga-68 PSMA PET/CT with the IPPC specifically to guide active surveillance is relatively new and has limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Istanbul, Turkey and 9 other locations
- Yeditepe University — Istanbul, Turkey, Turkey (Türkiye) (Recruiting)
- Bilkent Şehir Hastanesi — Ankara, Turkey (Türkiye) (Recruiting)
- Gazi Yaşargil Egitim ve Arastirma Hastanesi — Diyarbakır, Turkey (Türkiye) (Recruiting)
- Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi — Gaziantep, Turkey (Türkiye) (Recruiting)
- Acibadem University Altunizade Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Acibadem University Maslak Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Haseki Eğitim ve Araştırma Hastanesi — Istanbul, Turkey (Türkiye) (Recruiting)
- Istanbul University-Cerrahpaşa — Istanbul, Turkey (Türkiye) (Recruiting)
- SBÜ Başakşehir Çam Sakura Şehir hastanesi — Istanbul, Turkey (Türkiye) (Recruiting)
- Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Levent Kabasakal, Prof. MD — Istanbul University - Cerrahpasa
- Study coordinator: Levent Kabasakal, Prof. MD
- Email: lkabasakal@tsnm.org
- Phone: 00905323667908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.