Prostate CancerMR-PROPERNCT03225222
MRI in PROstate Cancer Diagnosis With Prior Risk Assessment
An observational study of Prostate Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- biopsy
- How many people
- 2,558 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2017to 31 Jan 2021
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men are eligible for the study if there is a clinical suspicion of harbouring prostate cancer without previous prostate biopsies. This essentially includes men with an elevated PSA (≥ 3 ng/ml) and/or a suspicious DRE, or family history of prostate cancer.
Who may be able to join
- men ≥ 50 years,
- no prior prostate biopsies,
- suspected of having prostate cancer based on PSA blood test (≥ 3 ng/ml) and/or DRE( digital rectal examination) and/or family history of prostate cancer,
- fit to undergo all protocol procedures,
- signed informed consent.
Who cannot join
- contra-indications to MRI or TRUS biopsy procedures,
- any medical condition precluding procedures described in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.
Read the detailed description
Screening for prostate cancer (PCa) remains one of the most controversial issues in urological practice. Although robust data from the European Randomised study of Screening for Prostate Cancer (ERSPC) suggest a disease specific survival benefit in favor of prostate-specific antigen (PSA)-based PCa screening, the coinciding unfavorable harm-benefit precludes that PCa screening can be adopted as a public health policy. The diagnostic pathway needs to be optimized to reduce unnecessary testing and to avoid diagnosing those cancers that will never harm a patient if not detected through screening. Some men may thus benefit from PCa screening, but with the currently used diagnostics (i.e. the PSA test and systematic TRUS (transrectal ultrasound )-guided prostate biopsy) many more men are harmed by unnecessary testing and the cascade of diagnostic and treatment related events that follow.
Further refinements to screening strategies, focusing on detecting only those PCa that are potentially life threatening (clinically significant) are needed to become acceptable to the general population and health care providers. The investigators propose such a refinement within this protocol, with upfront individual risk prediction and in addition a MRI-driven diagnostic pathway in only those men that are considered to be at intermediate/high-risk of having a potentially life threatening PCa (in general defined as Gleason sum Score (GS) =7).
- Conditions
- Prostate Cancer
- Being tested
- biopsy
- Keywords
- Prostate cancer, multivariate risk assessment, MRI, biopsy, screening, multicenter
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyDiagnostic test
prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Low-risk PCa | No TRUS-guided biopsy | |
| Intermediate/high-risk PCa (Control) | TRUS-guided biopsy 'only' (current standard practice). Receives: Diagnostic Test: biopsy | |
| Intermediate/high-risk PCa (Intervention 1) | TRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies. Receives: Diagnostic Test: biopsy | |
| Intermediate/high-risk PCa (Intervention 2) | MRI-'first', followed by TRUS-guided and targeted biopsies. Receives: Diagnostic Test: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of detected csPCa
Proportion of study population with clinically significant prostate cancer (csPCa), correctly identified by Risk-assessment + MRI-driven pathway
Measured: 36 months
Secondary outcomes (3)
Number of biopsy procedures in relation to detected csPCa.
Number of prostate biopsy procedures in relation to the detection of clinically significant prostate cancer.
Measured: 36 months
Proportion of unnecessary TRUS-guided and targeted biopsies
Proportion of TRUS-guided and targeted biopsies that could have been avoided safely.
Measured: 36 months
CEA Risk stratification-MRI
Diagnostic health care cost-effectiveness analysis (CEA) of Risicowijzer-MRI-driven pathway.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Nov 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,558 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivo G. Schoots, Erasmus Medical Center
- Investigators
- Ivo Schoots, Dr, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225222
- Sponsor's protocol ID
- OZBS92.16132
- Acronym
- MR-PROPER
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2017
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still under consideration
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI in PROstate Cancer Diagnosis With Prior Risk Assessment
- ClinicalTrials.gov ID
- NCT03225222
- Acronym / sponsor ID
- MR-PROPER / OZBS92.16132
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, multivariate risk assessment, MRI, biopsy, screening, multicenter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,558 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 21 Jul 2017 (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.
To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.
Detailed description
Screening for prostate cancer (PCa) remains one of the most controversial issues in urological practice. Although robust data from the European Randomised study of Screening for Prostate Cancer (ERSPC) suggest a disease specific survival benefit in favor of prostate-specific antigen (PSA)-based PCa screening, the coinciding unfavorable harm-benefit precludes that PCa screening can be adopted as a public health policy. The diagnostic pathway needs to be optimized to reduce unnecessary testing and to avoid diagnosing those cancers that will never harm a patient if not detected through screening. Some men may thus benefit from PCa screening, but with the currently used diagnostics (i.e. the PSA test and systematic TRUS (transrectal ultrasound )-guided prostate biopsy) many more men are harmed by unnecessary testing and the cascade of diagnostic and treatment related events that follow.
Further refinements to screening strategies, focusing on detecting only those PCa that are potentially life threatening (clinically significant) are needed to become acceptable to the general population and health care providers. The investigators propose such a refinement within this protocol, with upfront individual risk prediction and in addition a MRI-driven diagnostic pathway in only those men that are considered to be at intermediate/high-risk of having a potentially life threatening PCa (in general defined as Gleason sum Score (GS) =7).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-risk PCa | – | –No TRUS-guided biopsy |
| Intermediate/high-risk PCa (Control) | – | Diagnostic Test: biopsyTRUS-guided biopsy 'only' (current standard practice). |
| Intermediate/high-risk PCa (Intervention 1) | – | Diagnostic Test: biopsyTRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies. |
| Intermediate/high-risk PCa (Intervention 2) | – | Diagnostic Test: biopsyMRI-'first', followed by TRUS-guided and targeted biopsies. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men are eligible for the study if there is a clinical suspicion of harbouring prostate cancer without previous prostate biopsies. This essentially includes men with an elevated PSA (≥ 3 ng/ml) and/or a suspicious DRE, or family history of prostate cancer.
Key inclusion criteria (5 listed)
- men ≥ 50 years,
- no prior prostate biopsies,
- suspected of having prostate cancer based on PSA blood test (≥ 3 ng/ml) and/or DRE( digital rectal examination) and/or family history of prostate cancer,
- fit to undergo all protocol procedures,
- signed informed consent.
Key exclusion criteria (2 listed)
- contra-indications to MRI or TRUS biopsy procedures,
- any medical condition precluding procedures described in the protocol
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 |
|---|---|---|
| biopsyprostate biopsy | Diagnostic test | Intermediate/high-risk PCa (Control), Intermediate/high-risk PCa (Intervention 1), Intermediate/high-risk PCa (Intervention 2) |
Primary outcome
Proportion of detected csPCa
Time frame: 36 months
Proportion of study population with clinically significant prostate cancer (csPCa), correctly identified by Risk-assessment + MRI-driven pathway
3 secondary outcomes
Number of biopsy procedures in relation to detected csPCa.
Time frame: 36 months
Proportion of unnecessary TRUS-guided and targeted biopsies
Time frame: 36 months
CEA Risk stratification-MRI
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided. Still under consideration
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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. This study is not recruiting at the moment.
Ivo Schoots, Dr principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of detected csPCa (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2023.