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

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.

Eligibility

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

Conditions3

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