Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ga-68 PSMA11 PET/CT
Treatment groups
No treatment groups listed
Sponsors and collaborators
Istanbul University - Cerrahpasa
Lead sponsor
Yeditepe University
Collaborator
Yedikule Training and Research Hospital
Collaborator
Acibadem University
Collaborator
Ankara Yildirim Beyazıt University
Collaborator
University of Gaziantep
Collaborator
Istanbul Training and Research Hospital
Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Collaborator
Sisli Hamidiye Etfal Training and Research Hospital
Collaborator
Haseki Training and Research Hospital
Collaborator
Source ClinicalTrials.gov