MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: biopsy

• Registration Number: NCT03225222
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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 Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-11-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2558

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intermediate/high-risk PCa (Intervention 1)	biopsy	TRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies.
Intermediate/high-risk PCa (Control)	biopsy	TRUS-guided biopsy 'only' (current standard practice).
Intermediate/high-risk PCa (Intervention 2)	biopsy	MRI-'first', followed by TRUS-guided and targeted biopsies.

Primary Outcome Measures

Name	Time	Method
Proportion of detected csPCa	36 months	Proportion of study population with clinically significant prostate cancer (csPCa), correctly identified by Risk-assessment + MRI-driven pathway

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasmusmc; 🇳🇱 Rotterdam, Zuid Holland, Netherlands