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
This trial does not accept healthy volunteersQualifiers
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 population
Only Turkish patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ga-68 PSMA11 PET/CT
Diagnostic testdelayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa)
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for IPPC classification in identifying csPCa, defined as ISUP Grade Group ≥2 on radical prostatectomy pathology or disease progression on long-term follow-up.
Time frame
Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.Secondary outcomes
1
Reduction in Repeat Biopsy Rate
Percentage of patients avoiding unnecessary repeat biopsies due to IPPC classification, compared with historical AS protocols
Time frame
Assessed over 2 years.Other outcomes
1
Role of PSMA PET/CT During Active Surveillance
During follow-up, participants will undergo PSMA PET/CT either when clinical or biochemical progression is suspected, or annually even without evidence of progression. This will allow evaluation of whether PSMA PET/CT has a role in guiding patient management during Active Surveillance.
Time frame
Baseline imaging; confirmed at prostatectomy or through 2-year follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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