MRI in PROstate Cancer Diagnosis With Prior Risk Assessment (MR-PROPER)

To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: biopsy

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 Type: Observational
• Enrollment (Actual): 2558

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015CE
      • ErasmusMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low-risk PCa; No TRUS-guided biopsy
Intermediate/high-risk PCa (Control); TRUS-guided biopsy 'only' (current standard practice).	Diagnostic test: biopsy; prostate biopsy
Intermediate/high-risk PCa (Intervention 1); TRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies.	Diagnostic test: biopsy; prostate biopsy
Intermediate/high-risk PCa (Intervention 2); MRI-'first', followed by TRUS-guided and targeted biopsies.	Diagnostic test: biopsy; prostate biopsy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Ivo Schoots, Dr, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Prostate cancer; screening; multicenter; biopsy; multivariate risk assessment
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: OZBS92.16132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Still under consideration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No