MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

NCT ID: NCT03225222

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2558 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-01-31

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).

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low-risk PCa

No TRUS-guided biopsy

No interventions assigned to this group

Intermediate/high-risk PCa (Control)

TRUS-guided biopsy 'only' (current standard practice).

biopsy

Intervention Type: DIAGNOSTIC_TEST

prostate biopsy

Intermediate/high-risk PCa (Intervention 1)

TRUS-guided biopsy 'first'; if indicated followed by MRI and targeted biopsies.

biopsy

Intervention Type: DIAGNOSTIC_TEST

prostate biopsy

Intermediate/high-risk PCa (Intervention 2)

MRI-'first', followed by TRUS-guided and targeted biopsies.

biopsy

Intervention Type: DIAGNOSTIC_TEST

prostate biopsy

Interventions

biopsy

prostate biopsy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ivo G. Schoots

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivo Schoots, Dr

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmusmc

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

OZBS92.16132

Identifier Type: -

Identifier Source: org_study_id