Diagnostic Performance and Clinical Impact of PSMA PET/CT versus mpMRI in Patients with a High Suspicion of Prostate Cancer and Previously Negative Biopsy: A Prospective Trial (PROSPET-BX)

Background: This prospective single-arm study is designed to compare in parallel68Ga-PSMA PET/TRUS (transrectal or transperineal) fusion biopsy ( “experimental test”) with multiparametric MRI (mpMRI)/TRUS fusion prostate biopsy (“standard test”) in men with a high suspicion of prostate cancer (PCa) after at least one negative biopsy. The primary objective was to evaluate the diagnostic performance of68Ga-PSMA PET/TRUS fusion prostate biopsy in comparison to mpMRI/TRUS fusion prostate biopsy analyzed in parallel. Secondarily, we aimed to determine the relationship between the “experimental test” and the histopathological characteristics of the specimen, along with the clinical utility of the “experimental test” compared to the “standard test.”Summary: To test the superiority of68Ga-PSMA PET/CT compared to mpMRI, we will enroll a minimum cohort of 128 patients. Inclusion criteria comprise: age #x3e;18 years; blood PSA level #x3e;4.0 ng/mL; free-to-total PSA ratio #x3c;20%; progressive rise of PSA levels in two consecutive blood samples despite antibiotics; serum blood tests suspicious for PCa; at least one previous negative biopsy; ASAP and/or high-grade PIN; negative digital rectal examination. All eligible patients will undergo68Ga-PSMA PET/CT and mpMRI scans within 1 month ’s distance from each other, followed by biopsy session to be completed within 1 month’s distance. Targeted TRUS fusion needle biopsy will be performed for all lesions detected with...
Source: Urologia Internationalis - Category: Urology & Nephrology Source Type: research