MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

Study Overview
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Brief Summary
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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
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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).

Official Title
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MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: contra-indications to MRI or TRUS biopsy procedures, any medical condition precluding procedures described in the protocol

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low-risk PCa<br>No TRUS-guided biopsy | |
| Intermediate/high-risk PCa (Control)<br>TRUS-guided biopsy 'only' (current standard practice). | Diagnostic Test: biopsy<br>* prostate biopsy<br>|
| Intermediate/high-risk PCa (Intervention 1)<br>TRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies. | Diagnostic Test: biopsy<br>* prostate biopsy<br>|
| Intermediate/high-risk PCa (Intervention 2)<br>MRI-'first', followed by TRUS-guided and targeted biopsies. | Diagnostic Test: biopsy<br>* prostate biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of detected csPCa | Proportion of study population with clinically significant prostate cancer (csPCa), correctly identified by Risk-assessment + MRI-driven pathway | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of biopsy procedures in relation to detected csPCa. | Number of prostate biopsy procedures in relation to the detection of clinically significant prostate cancer. | 36 months | 
| Proportion of unnecessary TRUS-guided and targeted biopsies | Proportion of TRUS-guided and targeted biopsies that could have been avoided safely. | 36 months | 
| CEA Risk stratification-MRI | Diagnostic health care cost-effectiveness analysis (CEA) of Risicowijzer-MRI-driven pathway. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, multivariate risk assessment, MRI, biopsy, screening, multicenter