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

Erasmus University

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03225222

OZBS92.16132

Details and patient eligibility

About

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

Full 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).

Enrollment: 2,558 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,558 participants in 4 patient groups

Low-risk PCa

Description:

No TRUS-guided biopsy

Intermediate/high-risk PCa (Control)

Description:

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

Treatment:

Diagnostic Test: biopsy

Intermediate/high-risk PCa (Intervention 1)

Description:

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

Treatment:

Diagnostic Test: biopsy

Intermediate/high-risk PCa (Intervention 2)

Description:

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

Treatment:

Diagnostic Test: biopsy