Prospective Evaluation of Proclarix® Test to Improve Risk Stratification in Men Scheduled for MpMRI and Prostate Biopsy in Cantonal Hospital Aarau

RecruitingOBSERVATIONAL
Enrollment

480

Participants

Timeline

Start Date

August 24, 2022

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2026

Conditions
Prostate Cancer
Interventions
DIAGNOSTIC_TEST

Proclarix®

The aim of the study is the implementation of new biomarkers (Proclarix®) in order to increase the sensitivity and specificity of PSA-based Prostate cancer early detection avoiding unnecessary prostate biopsies thus decreasing the associated morbidity (infections, bleeding, urinary retention, etc.). PSA values, Proclarix and mpMRI findings will be correlated with the results of the prostate biopsy in order to improve patient selection for future biopsies in order to avoid unnecessary prostate biopsies, but still be able to detect relevant carcinomas at an early stage. The null hypothesis in our observational study is the lack of superiority in PCa early detection when using the Proclarix over PSA alone.

Trial Locations (1)

5001

RECRUITING

Cantonal Hospital Aarau, Aarau

All Listed Sponsors
lead

Kantonsspital Aarau

OTHER