# Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Combination of PSA/DRE and Multi Parametric Magnetic Resonance Imaging

> **NCT04993508** · NA · NOT_YET_RECRUITING · sponsor: **Heinrich-Heine University, Duesseldorf** · enrollment: 1908 (estimated)

## Conditions studied

- Prostate Cancer

## Interventions

- **DIAGNOSTIC_TEST:** PSA test
- **DEVICE:** multiparametric prostate Magnetic Resonance Imaging (mpMRI)
- **PROCEDURE:** targeted MRI/US fusion-guided biopsy
- **PROCEDURE:** combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy)
- **PROCEDURE:** MRI inbore biopsy

## Key facts

- **NCT ID:** NCT04993508
- **Lead sponsor:** Heinrich-Heine University, Duesseldorf
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-04-01
- **Primary completion:** 2030-03-31
- **Final completion:** 2030-03-31
- **Target enrollment:** 1908 (ESTIMATED)
- **Last updated:** 2025-09-26

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04993508

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04993508, "Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Combination of PSA/DRE and Multi Parametric Magnetic Resonance Imaging". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT04993508. Licensed CC0.

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