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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019892

Enrollment

640

Registered

2019-12-30

Start date

2020-01-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: SelectMDx - Test

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria

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.)

Design outcomes

Secondary

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

Measure

Time frame

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

—

Primary

Measure	Time frame
A minimum 10% improvement of the diagnostic accuracy of the multi parametric MRI of the prostate	—

Countries

Austria, Germany

Contacts

Public ContactSamy Mahjoub

Klinik für Urologie Uniklinik Köln

samy.mahjoub@uk-koeln.de0221 - 478 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026