Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance

What this study 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.

+Read the 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.

Primary outcome measures

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.

Who can take part

SexMALEAge18 Years to no upper limitHealthy volunteersNo

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

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites

Acıbadem Altunizade Hospital, IstanbulRecruiting
Acıbadem Maslak Hospital, IstanbulRecruiting

Also running at 8 other sites in 1 countries.

Study of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance

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