Improvement of detection of clinically significant prostate cancer by combination of molecular urine markers and multiparametric MRI of the prostate

Phase 4

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00019892
• Lead Sponsor: Klinik für Urologie Uniklinik Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 640

Inclusion Criteria

Life expectancy > 10 years
- Clinical suspicion of prostate cancer (PSA > 4.0ng/ml and/or positive digitorectal examination)

Exclusion Criteria

- Prostate cancer in medical history
- Acute prostatitis in the last 6 months
- PSA > 20 ng/ml
- Contraindicaitons for a mpMRI
- PSA affecting interventions (e.g. medication such as 5-alpha reductase inhibitors, azaleas, bicalutamide etc.)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A minimum 10% improvement of the diagnostic accuracy of the multi parametric MRI of the prostate

Secondary Outcome Measures

Name	Time	Method
- Reduction of the rate of unnecessary biopsies<br>- Reduction of the rate of over-diagnoses<br>- Development of a predictive nomogram<br>- Sensitivity, specificity, negative predictive value and positive predictive value of the SelectMDx-Test for patients with negative mpMRI and for PI-RADS 3 lesions<br>- Type and frequency of adverse events of the mpMRI and the targeted biopsy<br>- Cost effectiveness analysis with significant cost reduction by avoiding unnecessary mpMRIs and prostate biopsies<br>