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Clinical trial Recruiting at 1 site Observational Ages 45 to 80 Men only

Evaluating Proclarix® for better prostate cancer risk assessment

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

Run by Kantonsspital Aarau · NCT06637267 · Data updated 2026-11-12

This study is testing if the Proclarix test can help better identify men at risk for significant prostate cancer when used with regular PSA tests, aiming to reduce unnecessary biopsies.

Quick facts

Study typeObservational
Ages45 Years to 80 Years
SexMen only
Enrollment480 (estimated)
SponsorKantonsspital Aarau
Academic / other
Drugs / interventionsradiation
Locations1 site (Aarau, Canton of Aargau)
StatusRecruiting
StartedAugust 24, 2022
Main results expectedDecember 30, 2025
Study endsDecember 30, 2026
Registry record updatedOctober 15, 2024
Trial IDNCT06637267 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are male patients aged 45 to 80 who are scheduled for mpMRI and prostate biopsy.

Probably not a fit

Patients who have had previous prostate treatments or acute urinary tract infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to improve the early detection of prostate cancer by implementing the Proclarix test alongside traditional prostate-specific antigen (PSA) testing. It will assess the sensitivity and specificity of Proclarix in predicting significant prostate cancer compared to PSA levels and mpMRI findings. The goal is to reduce unnecessary prostate biopsies, which can lead to complications, while still identifying relevant cancers at an early stage. The study will correlate various clinical parameters to develop a predictive risk stratification tool for prostate cancer.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the number of unnecessary prostate biopsies and associated complications for patients.

How similar studies have gone: While there have been various studies on prostate cancer risk calculators, the specific use of Proclarix in this context is a novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male patients between 45 and 80 years of age who are scheduled for an mpMRI followed by prostate biopsy (systematic and / or TRUS fusion biopsy) - within the framework of standard of care
* Signed ICE

Exclusion Criteria:

* patients who had previous treatments of the prostate (TUR prostate, cryoablation, HIFU, IRE, radiation therapy, alcohol instillation, etc.) in the past 5 years.
* acute urinary tract infections.
* the use of 5-alpha reductase inhibitors.
* mpMRI performed outside of the scope of Kantonsspital Aarau.

Where it's running

  • Cantonal Hospital Aarau
    Aarau, Canton of Aargau, Switzerland     Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.