MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

Prostate Cancer Clinical Trial

— MR-PROPER  

Official title:

MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225222
• Other study ID #: OZBS92.16132
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2558
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• biopsy
prostate biopsy

Locations

Country	Name	City	State
Netherlands	Erasmusmc	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of unnecessary TRUS-guided and targeted biopsies	Proportion of TRUS-guided and targeted biopsies that could have been avoided safely.	36 months
Secondary	CEA Risk stratification-MRI	Diagnostic health care cost-effectiveness analysis (CEA) of Risicowijzer-MRI-driven pathway.	36 months