Actively Recruiting
Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Led by Istanbul University - Cerrahpasa · Updated on 2025-09-15
201
Participants Needed
10
Research Sites
143 weeks
Total Duration
On this page
Sponsors
I
Istanbul University - Cerrahpasa
Lead Sponsor
Y
Yeditepe University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- mpMRI performed within 3 months prior to enrollment
- Systematic or MRI-targeted prostate biopsy performed
- Biopsy-confirmed ISUP Grade 1 low-risk prostate cancer
- Prostate biopsy report specifying tumor location and number of positive cores
- Meets active surveillance criteria: ISUP 1, PSA 6 10 ng/mL, PSA density 6 0.15 ng/mL�b2, clinical stage cT1c-T2a, 6 3 positive cores
- Life expectancy of at least 10 years
- No prior PSMA PET imaging
- No signs of extra-prostatic disease on mpMRI
- Signed informed consent for study procedures
You will not qualify if you...
- High-risk or unfavorable intermediate-risk prostate cancer 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 less than 10 years
- Severe kidney problems
- Inability to comply with follow-up schedule
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Yeditepe University
Istanbul, Turkey, Turkey (Türkiye), 34000
Actively Recruiting
2
Bilkent Şehir Hastanesi
Ankara, Turkey (Türkiye)
Actively Recruiting
3
Gazi Yaşargil Egitim ve Arastirma Hastanesi
Diyarbakır, Turkey (Türkiye)
Actively Recruiting
4
Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi
Gaziantep, Turkey (Türkiye)
Actively Recruiting
5
Acibadem University Altunizade Hospital
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
6
Acibadem University Maslak Hospital
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
7
Haseki Eğitim ve Araştırma Hastanesi
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
8
Istanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
9
SBÜ Başakşehir Çam Sakura Şehir hastanesi
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
10
Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
Research Team
L
Levent Kabasakal, Prof. MD
CONTACT
N
Nalan Alan, Prof. MD.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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