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NCT Number: 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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Men at the age of 50 to 75 years with an elevated PSA (≥ 3 ng/ml) and/or suspicious DRE receive a multiparametric MRI (mpMRI) and will be stratified based on MRI results. Only men with suspicious MRI, PI-RADS 4/5, and PI-RADS 3 in conjunction with high PSA density (PSAD > 0.15) are biopsied.

These will be randomized into arms A nd B. While patients in arm A undergo only targeted MRI/US fusion-guided biopsies (TB), patients in the "combined" arm B receive systematic biopsies (SB) and TB.

Statistical analysis for the detection rate of clinically significant and insignificant prostate cancers is composed of testing the non-inferiority and superiority of TB vs. TB+SB, respectively, using a global significance level of α = 0.05.

Interventions that are conducted within the PRIMA trial include PSA testing, digital rectal examination of the prostate (DRE), multiparametric prostate MRI, systematic and MRI/US fusion-guided biopsies as well as MRI inbore biopsies.

Arms A + B: Men with PI-RADS 4/5 and PI-RADS 3 in conjunction with PSAD > 0.15 will be randomized into arm A or arm B and biopsied as explained above. Men with PI-RADS 3 and PSAD > 0.15 with negative biopsy results will receive a follow-up MRI after 12 months. In case of upgrade to PI-RADS 4/5, men will be re-biopsied. Men with PI-RADS 4/5 without cancer diagnosis or with clinically insignificant cancer in the subsequent biopsy will be offered an additional MRI inbore biopsy. If MRI inbore biopsy is negative or with clinically insignificant cancer in men with PI-RADS 4/5, men will be followed-up with MRI after 12 months. In the case of persistent PI-RADS 4/5, men will be re-biopsied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men aged from 50 to 75 years
  • elevated PSA ≥ 3 ng/ml and/or cancer suspicious DRE

Exclusion criteria

  • Men with known prostate cancer
  • men with prior prostate biopsy
  • men with non-MRI compatible devices
  • men with acute prostatitis

Treatment and study plan

PSA test

Diagnostic Test

testing for blood levels of PSA

multiparametric prostate Magnetic Resonance Imaging (mpMRI)

Device

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.

targeted MRI/US fusion-guided biopsy

Procedure

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.

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

Procedure

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.

MRI inbore biopsy

Procedure

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.

Primary outcomes

  1. detection rate of clinically significant and insignificant prostate cancers

    Time frame: 48 months

    The composite primary endpoint comprises non-inferiority in detecting clinically significant prostate cancer (ISUP grade group ≥ 2) and superiority in avoiding detection of clinically insignificant prostate cancer (ISUP grade group 1) of TB (arm A) compared to TB+SB (arm B)

Secondary outcomes

  1. Pain score (Visual Analogue Scale [VAS])

    Time frame: 48 months

    Patient Reported Outcomes (PROs) - diagnostic burden in arm A and B

  2. Patient Reported Outcomes (PROs) - complications after biopsy

    Time frame: 30-day

    30-day complication-rate after biopsy in arm A and B

  3. Patient Reported Outcomes (PROs) - quality of life according to EORTC-QLQ-C30

    Time frame: 48 months

    quality of life according to EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer - Quality of Life of Cancer Patientes; Scoring according to manual) in all different study arms

  4. Patient Reported Outcomes (PROs) - quality of life according to EPIC-26

    Time frame: 48 months

    quality of life according to EPIC-26 (Expanded prostate cancer index composite; Scoring according to manual) in all different study arms

  5. number of biopsies avoided

    Time frame: 48 months

    Number of biopsies avoided with pre-biopsy mpMRI

  6. detection rate of MRI inbore biopsy

    Time frame: 48 months

    Detection rate of MRI inbore biopsy after negative TB

  7. detection rate of biparametric MRI

    Time frame: 48 months

    Detection rate of biparametric MRI (no perfusion imaging)

  8. Number of up- and downgrading of PI-RADS score

    Time frame: 48 months

    Number of up- and downgradings of PI-RADS (Prostate Imaging - Reporting and Data System) score in follow-up mpMRIs

  9. IPSS

    Time frame: 48 months

    International Prostate Symptom Score

  10. IIEF-6

    Time frame: 48 months

    International Index of Erectile Function

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Droop, PhD

CONTACT

[email protected]

+49 0211 81 19414

Rouvier Al-Monajjed, MD

CONTACT

[email protected]

+49 0211 81 18110

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • Evangelische Kliniken Essen-Mitte
  • German Cancer Research Center
  • Klinikum Dortmund
  • Marienhospital Herne
  • Stiftungsklinikum PROSELIS gGmbH Recklinghausen
  • Städtische Kliniken Mönchengladbach
  • University Hospital Muenster
  • University Hospital of Cologne
  • University Hospital, Aachen
  • University Hospital, Bonn
  • University Hospital, Essen

Registry information

Acronym: PRIMA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 6, 2021
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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