Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study

Shanghai East Hospital1 site in 1 country500 target enrollmentDecember 1, 2022

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Shanghai East Hospital
Enrollment: 500
Locations: 1
Primary Endpoint: The proportion of men with clinically significant cancer
Status: Not Yet Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening

Registry

clinicaltrials.gov

Start Date

December 1, 2022

End Date

December 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Shanghai East Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•age between 18 and 80 years old
•life-expectancy at least 10 years
•fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria

•Already diagnosis with prostate cancer;
•cannot tolerate prostate biopsy or has contraindication to biopsy;
•cannot tolerate prostate biopsy or has contraindication to MRI examination;
•undergo biopsy within 1 year
•patients judged by the investigator to be unsuitable to participate in the clinical trial;

Outcomes

Primary Outcomes

The proportion of men with clinically significant cancer

Time Frame: Within 1 month after the biopsy

The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more

Secondary Outcomes

The proportion of men with clinically insignificant cancer(Within 1 month after the biopsy)
The proportion of men who do not undergo biopsy(Within 1 month after the biopsy)
The proportion of men with adverse events after the intervention(Within 1 week after the biopsy)