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

Launched by KANTONSSPITAL AARAU · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test called Proclarix, which aims to improve how doctors assess the risk of prostate cancer in men who are scheduled for an MRI and a prostate biopsy. The Proclarix test combines two new biomarkers with traditional prostate-specific antigen (PSA) levels and the patient's age to create a more accurate risk assessment. This is important because many current methods for predicting prostate cancer risk do not consider recent advancements in medical imaging and laboratory technology.

To participate in this trial, men aged 45 to 80 who are set to undergo an MRI and biopsy at the Cantonal Hospital Aarau may be eligible. However, those who have had previous prostate treatments in the last five years or have certain medical conditions, like acute urinary tract infections, will not qualify. Participants can expect to undergo the standard MRI and biopsy procedures, but their results will also include insights from the Proclarix test, which may help to avoid unnecessary biopsies and provide a clearer picture of their prostate health.

Gender

MALE

Eligibility 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.