Prostate CancerPRIMANCT04993508
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
A study testing PSA test, multiparametric prostate Magnetic Resonance Imaging (mpMRI) and targeted MRI/US fusion-guided biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSA test, multiparametric prostate Magnetic Resonance Imaging (mpMRI) and targeted MRI/US fusion-guided biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,908 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged from 50 to 75 years
- elevated PSA ≥ 3 ng/ml and/or cancer suspicious DRE
Who cannot join
- Men with known prostate cancer
- men with prior prostate biopsy
- men with non-MRI compatible devices
- men with acute prostatitis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- PSA test, multiparametric prostate Magnetic Resonance Imaging (mpMRI), targeted MRI/US fusion-guided biopsy, combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy), MRI inbore biopsy
- Keywords
- prostate cancer, prostate cancer diagnosis, multiparametric Magnetic Resonance Imaging (mpMRI), detection of clinically significant prostate cancer, avoidance of over diagnosis, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA testDiagnostic 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 biopsyProcedure or surgery
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 or surgery
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 biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Men with PI-RADS 4/5 or PI-RADS 3 in conjunction with PSAD ≥ 0.15 that are randomized into arm A will undergo only targeted MRI/US fusion-guided biopsies. 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, men will be followed-up with MRI after 12 months. In the case of persistent PI-RADS 4/5, men will be re-biopsied. Receives: Diagnostic Test: PSA test; Device: multiparametric prostate Magnetic Resonance Imaging (mpMRI); Procedure: targeted MRI/US fusion-guided biopsy; Procedure: MRI inbore biopsy |
| Arm B | Active comparator | Men with PI-RADS 4/5 or PI-RADS 3 in conjunction with PSAD ≥ 0.15 that are randomized into arm B will undergo targeted MRI/US fusion-guided biopsies and systematic biopsies (standard of care). 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, men will be followed-up with MRI after 12 months. In the case of persistent PI-RADS 4/5, men will be re-biopsied. Receives: Diagnostic Test: PSA test; Device: multiparametric prostate Magnetic Resonance Imaging (mpMRI); Procedure: combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy); Procedure: MRI inbore biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of clinically significant and insignificant prostate cancers
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)
Measured: 48 months
Secondary outcomes (10)
Pain score (Visual Analogue Scale [VAS])
Patient Reported Outcomes (PROs) - diagnostic burden in arm A and B
Measured: 48 months
Patient Reported Outcomes (PROs) - complications after biopsy
30-day complication-rate after biopsy in arm A and B
Measured: 30-day
Patient Reported Outcomes (PROs) - quality of life according to EORTC-QLQ-C30
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
Measured: 48 months
Patient Reported Outcomes (PROs) - quality of life according to EPIC-26
quality of life according to EPIC-26 (Expanded prostate cancer index composite; Scoring according to manual) in all different study arms
Measured: 48 months
number of biopsies avoided
Number of biopsies avoided with pre-biopsy mpMRI
Measured: 48 months
detection rate of MRI inbore biopsy
Detection rate of MRI inbore biopsy after negative TB
Measured: 48 months
detection rate of biparametric MRI
Detection rate of biparametric MRI (no perfusion imaging)
Measured: 48 months
Number of up- and downgrading of PI-RADS score
Number of up- and downgradings of PI-RADS (Prostate Imaging - Reporting and Data System) score in follow-up mpMRIs
Measured: 48 months
IPSS
International Prostate Symptom Score
Measured: 48 months
IIEF-6
International Index of Erectile Function
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,908 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Aachen, University Hospital, Bonn, University Hospital of Cologne, University Hospital, Essen, University Hospital Muenster, German Cancer Research Center, Marienhospital Herne, Städtische Kliniken Mönchengladbach, Evangelische Kliniken Essen-Mitte, Klinikum Dortmund, Stiftungsklinikum PROSELIS gGmbH Recklinghausen
- Responsible party
- Sponsor
- Investigators
- Rouvier Al-Monajjed, MD, Principal investigator, Heinrich Heine University Düsseldorf / UrologyLars Schimmöller, MD, Principal investigator, Heinrich Heine University Düsseldorf / RadiologyPeter Albers, MD, Study chair, Heinrich Heine University Düsseldorf / UrologyGerald Antoch, MD, Study chair, Heinrich Heine University Düsseldorf / RadiologyMatthias Boschheidgen, MD, Study chair, Heinrich Heine University Düsseldorf / RadiologyJan Philipp Radtke, MD, Study chair, Heinrich Heine University Düsseldorf / UrologyAxel Benner, Study chair, German Cancer Research Center / BiostatisticsBoris Hadaschik, MD, Study chair, University Hospital Essen / Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993508
- Sponsor's protocol ID
- 2021-1389
- Acronym
- PRIMA
- Status last verified
- Sep 2024
- First submitted
- 8 Jun 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Monajjed R, Albers P, Boschheidgen M, Radtke JP, Droop J, Benner A, Hadaschik B, Antoch G, Schimmoller L; PRIMA Study Group. PRIMA: randomized prospective multicenter non-inferiority study for primary diagnosis of clinically significant PRostate cancer by PSA and MR IMAging-study protocol for a randomized diagnostic accuracy trial. Trials. 2026 Apr 25;27(1):320. doi: 10.1186/s13063-026-09750-z.
PubMed 42032761
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04993508
- Acronym / sponsor ID
- PRIMA / 2021-1389
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate cancer diagnosis, multiparametric Magnetic Resonance Imaging (mpMRI), detection of clinically significant prostate cancer, avoidance of over diagnosis, PSA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,908 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University Hospital, Aachen, University Hospital, Bonn, University Hospital of Cologne, University Hospital, Essen, University Hospital Muenster, German Cancer Research Center, Marienhospital Herne, Städtische Kliniken Mönchengladbach, Evangelische Kliniken Essen-Mitte, Klinikum Dortmund, Stiftungsklinikum PROSELIS gGmbH Recklinghausen
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Diagnostic Test: PSA test, Device: multiparametric prostate Magnetic Resonance Imaging (mpMRI), Procedure: targeted MRI/US fusion-guided biopsy, Procedure: MRI inbore biopsyMen with PI-RADS 4/5 or PI-RADS 3 in conjunction with PSAD ≥ 0.15 that are randomized into arm A will undergo only targeted MRI/US fusion-guided biopsies. 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, men will be followed-up with MRI after 12 months. In the case of persistent PI-RADS 4/5, men will be re-biopsied. |
| Arm B | Active comparator | Diagnostic Test: PSA test, Device: multiparametric prostate Magnetic Resonance Imaging (mpMRI), Procedure: combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy), Procedure: MRI inbore biopsyMen with PI-RADS 4/5 or PI-RADS 3 in conjunction with PSAD ≥ 0.15 that are randomized into arm B will undergo targeted MRI/US fusion-guided biopsies and systematic biopsies (standard of care). 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, 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 may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged from 50 to 75 years
- elevated PSA ≥ 3 ng/ml and/or cancer suspicious DRE
Key exclusion criteria (4 listed)
- Men with known prostate cancer
- men with prior prostate biopsy
- men with non-MRI compatible devices
- men with acute prostatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSA testtesting for blood levels of PSA | Diagnostic test | Arm A, Arm B |
| 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. | Device | Arm A, Arm B |
| targeted MRI/US fusion-guided biopsyTargeted 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 or surgery | Arm A |
| 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 or surgery | Arm B |
| MRI inbore biopsyMRI 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. | Procedure or surgery | Arm A, Arm B |
Primary outcome
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)
10 secondary outcomes
Pain score (Visual Analogue Scale [VAS])
Time frame: 48 months
Patient Reported Outcomes (PROs) - complications after biopsy
Time frame: 30-day
Patient Reported Outcomes (PROs) - quality of life according to EORTC-QLQ-C30
Time frame: 48 months
Patient Reported Outcomes (PROs) - quality of life according to EPIC-26
Time frame: 48 months
number of biopsies avoided
Time frame: 48 months
detection rate of MRI inbore biopsy
Time frame: 48 months
detection rate of biparametric MRI
Time frame: 48 months
Number of up- and downgrading of PI-RADS score
Time frame: 48 months
IPSS
Time frame: 48 months
IIEF-6
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 42032761Al-Monajjed R, Albers P, Boschheidgen M, Radtke JP, Droop J, Benner A, Hadaschik B, Antoch G, Schimmoller L; PRIMA Study Group. PRIMA: randomized prospective multicenter non-inferiority study for primary diagnosis of clinically significant PRostate cancer by PSA and MR IMAging-study protocol for a randomized diagnostic accuracy trial. Trials. 2026 Apr 25;27(1):320. doi: 10.1186/s13063-026-09750-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rouvier Al-Monajjed, MD principal investigator
Heinrich Heine University Düsseldorf / Urology
Lars Schimmöller, MD principal investigator
Heinrich Heine University Düsseldorf / Radiology
Peter Albers, MD study chair
Heinrich Heine University Düsseldorf / Urology
Questions about this trial
What is this clinical trial studying?
A study testing PSA test, multiparametric prostate Magnetic Resonance Imaging (mpMRI) and targeted MRI/US fusion-guided biopsy in people with Prostate Cancer, run by Heinrich-Heine University, Duesseldorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Droop, PhD (+49 0211 81 19414, johanna.droop@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate of clinically significant and insignificant prostate cancers (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.