Clinical Trial · NCT05297162

PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial

Overview

This is prospective single-arm case-control study designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy ("experimental test") with mpMRI/TRUS fusion prostate biopsy ("standard test") in men with a high suspicion of PCa after at least one negative biopsy.

Sponsor

Unknown Organization

Phase

N/A

Contacts

Egesta Lopci, MD, PhD (PRINCIPAL_INVESTIGATOR)

Egesta Lopci, MD, PhD (CONTACT)

egesta.lopci@gmail.com

+390282247542

ClinicalTrials.gov

NCT05297162

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

progressive rise of PSA levels in two consecutive blood samples despite antibiotics;
negative digital rectal examination.
at least one previous negative biopsy (min 12 cores);
ASAP and/or high-grade PIN;
blood PSA level \>4.0ng/ml;
free-to-total PSA ratio \<20%;
serum blood tests suspicious for PCa;

Exclusion

antiandrogen therapy;
prostate needle biopsy \<21 days before PET and/or mpMRI;
known active secondary cancer;
anaphylaxis against gadolinium-DOTA.
active prostatitis;
endorectal coil/probe not applicable;