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

Summary

This randomized prospective multi center study is designed to confirm a new diagnostic pathway in primary diagnosis of clinically significant prostate cancer by combination of serum levels of prostate specific antigen (PSA), digitorectal examination (DRE), and multiparametric magnetic resonance imaging (mpMRI). Men at the age of 50 to 75 with an elevated PSA (\>= 3 ng/ml) and /or suspicious DRE receive an upfront multi parametric MRI. Only men with MRI results suspicious of clinically significant prostate cancer will be biopsied. Those will be randomized into arm A and arm B. Arm A undergoes only targeted MRI/US fusion-guided biopsies (= TB with a maximum of 3 targets and 4 cores per target). Arm B receives systematic biopsies (= SB with 12 biopsy cores) and TB. Men with unsuspicious mpMRI will be receive follow-up according to current clinical standards. PRIMA will prospectively evaluate if stand-alone targeted MRI/US fusion-guided biopsy alone is sufficient to detect clinically significant prostate cancer (csPC with (ISUP grade group ≥ 2) and to avoid unnecessary detection of low-grade PC (ISUP 1) in biopsy-naïve men compared to a combined biopsy (systematic plus targeted) approach. The results of this study will directly influence clinical practice, will have a positive impact on patients' lives, and will lower the financial burden due to reduced overdiagnosis and over treatment.

Conditions

• Prostate Cancer

Interventions

DIAGNOSTIC_TEST

PSA test

testing for blood levels of PSA

DEVICE

multiparametric prostate Magnetic Resonance Imaging (mpMRI)

mpMRI acquisition and reporting will be performed according to the current version of the Prostate Imaging-Reporting and Data System (PI-RADS). MpMRI will be performed at the different study centers on a 3 Tesla MR scanner using multi-phased array surface coil. MpMRI includes T1-weighted and T2-weighted imaging (T1WI, T2WI), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE-MRI). Hyoscine butyl bromide will be administered to optimize image quality. Prostate imaging quality will be assessed by the prostate imaging quality score (PI-QUAL). In case of contraindications to MRI contrast agents, DCE will be omitted. In case of contraindications to hyoscine butyl bromide, it will be omitted. Lesions with a PI-RADS score of ≥ 4 and 3 with PSAD \> 0.15 will considered suspicious for csPCa.

PROCEDURE

targeted MRI/US fusion-guided biopsy

Targeted MRI/US fusion-guided biopsy (TB) are performed using transrectal ultrasound (max. 4 cores from 3 targets). MRI/US fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.

PROCEDURE

combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy)

The combined biopsy comprises systematic biopsy (SB) and targeted MRI/US fusion-guided biopsy (TB). They are performed using transrectal ultrasound (number of cores: SB 12 cores, TB max. 4 cores from 3 targets). MRI/US fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.

PROCEDURE

MRI inbore biopsy

MRI inbore biopsies will be offered after negative initial MRI/US fusion-guided biopsy or diagnosis of only clinically insignificant PCa in initial biopsy in arms A or B. Before performing MRI inbore biopsy the PI-RADS scoring will be re-confirmed. The number of cores will be 2 per target. In case of inaccurate needle position additional cores are allowed to ensure correct targeting. Needle position will be verified in 2 planes. Coverage with antibiotics has to be provided as per local standard of care.

Sponsors & Collaborators

• University Hospital, Aachen

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• University Hospital of Cologne

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• University Hospital Muenster

  collaborator OTHER

• German Cancer Research Center

  collaborator OTHER

• Marienhospital Herne

  collaborator OTHER

• Städtische Kliniken Mönchengladbach

  collaborator UNKNOWN

• Evangelische Kliniken Essen-Mitte

  collaborator UNKNOWN

• Klinikum Dortmund

  collaborator UNKNOWN

• Stiftungsklinikum PROSELIS gGmbH Recklinghausen

  collaborator UNKNOWN

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Rouvier Al-Monajjed, MD · Heinrich Heine University Düsseldorf / Urology

• Lars Schimmöller, MD · Heinrich Heine University Düsseldorf / Radiology

• Peter Albers, MD · Heinrich Heine University Düsseldorf / Urology

• Gerald Antoch, MD · Heinrich Heine University Düsseldorf / Radiology

• Matthias Boschheidgen, MD · Heinrich Heine University Düsseldorf / Radiology

• Jan Philipp Radtke, MD · Heinrich Heine University Düsseldorf / Urology

• Axel Benner · German Cancer Research Center / Biostatistics

• Boris Hadaschik, MD · University Hospital Essen / Urology

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2030-03-31

Completion

2030-03-31