Evaluating Proclarix® for better prostate cancer risk assessment
Prospective Evaluation of Proclarix® Test to Improve Risk Stratification in Men Scheduled for MpMRI and Prostate Biopsy in Cantonal Hospital Aarau
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 type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | Kantonsspital Aarau Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aarau, Canton of Aargau) |
| Trial ID | NCT06637267 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 45 to 80 who are scheduled for mpMRI and prostate biopsy.
Not a fit: Patients who have had previous prostate treatments or acute urinary tract infections may not benefit from this study.
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 performed: While there have been various studies on prostate cancer risk calculators, the specific use of Proclarix in this context is a novel approach.
Eligibility criteria
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 this trial is running
Aarau, Canton of Aargau
- Cantonal Hospital Aarau — Aarau, Canton of Aargau, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.