Status:
RECRUITING
Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Lead Sponsor:
Istanbul University - Cerrahpasa
Collaborating Sponsors:
Yeditepe University
Yedikule Training and Research Hospital
Conditions:
Low Risk Prostate Cancer
Clinically Significant Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
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) fo...
Detailed Description
Prostate cancer is the most common malignancy in men and demonstrates heterogeneous clinical behavior. While many low-risk patients have indolent disease, a subset harbors clinically significant prost...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT07168616
Start Date
September 1 2025
End Date
June 1 2028
Last Update
September 15 2025
Active Locations (10)
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1
Yeditepe University
Istanbul, Turkey, Turkey (Türkiye), 34000
2
Bilkent Şehir Hastanesi
Ankara, Turkey (Türkiye)
3
Gazi Yaşargil Egitim ve Arastirma Hastanesi
Diyarbakır, Turkey (Türkiye)
4
Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi
Gaziantep, Turkey (Türkiye)