Clinically Significant Prostate Cancer, Low Risk Prostate Cancer
Conditions
Keywords
PSMA PET/CT, Low risk prostate cancer, active surveillance, prostate cancer, clinically significant prostate cancer, Diagnosis of prostate cancer
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) 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.
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 prostate cancer (csPCa) requiring early intervention. Active Surveillance (AS) is widely used to avoid overtreatment; however, current selection criteria-PSA, DRE, biopsy Gleason score, number of positive cores, PSA density, and mpMRI-lack sufficient predictive accuracy. Studies indicate that up to 30% of patients classified as low-risk by biopsy are found to have higher-grade disease at radical prostatectomy. The Istanbul PSMA PET/CT Criteria (IPPC) were developed by a multidisciplinary expert panel in Turkey to classify intraprostatic lesions on delayed (120-minute) Ga-68 PSMA PET/CT imaging into three risk categories: * IPPC 1 No or homogeneous low uptake - safe for monitoring. * IPPC 2: Indeterminate uptake - AS with close follow-up. * IPPC 3: Focal, lentiform, high SUVmax ≥12 uptake in peripheral zone - definitive treatment recommended. This study will evaluate the diagnostic performance of IPPC compared to standard mpMRI and biopsy findings, using radical prostatectomy pathology or long-term clinical follow-up as the reference standard.
Interventions
DIAGNOSTIC_TESTGa-68 PSMA11 PET/CT
delayed (120-minute) Ga-68 PSMA PET/CT and will be evaluated by using Istanbul PSMA PET/CT Criteria (IPPC)
Sponsors
Yeditepe University
Yedikule Training and Research Hospital
Acibadem University
Ankara Yildirim Beyazıt University
University of Gaziantep
Istanbul Training and Research Hospital
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sisli Hamidiye Etfal Training and Research Hospital
Haseki Training and Research Hospital
Istanbul University - Cerrahpasa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Diagnostic Accuracy of the Istanbul PSMA PET/CT Criteria (IPPC) for Detecting Clinically Significant Prostate Cancer (csPCa) | Baseline imaging; confirmed at prostatectomy or through 2-year follow-up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Repeat Biopsy Rate | Assessed over 2 years. | Percentage of patients avoiding unnecessary repeat biopsies due to IPPC classification, compared with historical AS protocols |
Other
| Measure | Time frame | Description |
|---|---|---|
| Role of PSMA PET/CT During Active Surveillance | Baseline imaging; confirmed at prostatectomy or through 2-year follow-up. | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactLevent Kabasakal, Prof. MD
Backup ContactNalan Alan, Prof. MD.
Outcome results
None listed