Clinical Trial · NCT07168616

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

Overview

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.

Sponsor

Unknown Organization

Contacts

Nalan Alan, Prof. MD. (CONTACT)

nalanselcuk@yahoo.com

00905322940667

Levent Kabasakal, Prof. MD (CONTACT)

lkabasakal@tsnm.org

00905323667908

Levent Kabasakal, Prof. MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07168616

Drug / Compound

PSMA

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

No evidence of extra-prostatic disease on mpMRI
Biopsy-confirmed ISUP Grade 1 low-risk PCa
Systematic or MRI-targeted prostate biopsy performed
Meets AS criteria: ISUP 1, PSA ≤10 ng/mL, PSAd \>0.15 ng/mL², clinical stage cT1c-T2a, ≤3 positive cores
mpMRI performed within 3 months prior to enrollment
Life expectancy ≥10 years
Prostate biopsy report specifying tumor localization and number of positive cores
No prior PSMA PET imaging

Exclusion

Inability to comply with follow-up schedule
History of pelvic radiotherapy
Prior prostate cancer treatment or prostate surgery
Life expectancy \<10 years
MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis
Severe renal impairment