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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05025527
• Lead Sponsor: Shanghai East Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Study Start: 2022-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of men with clinically significant cancer	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 Outcome Measures

Name	Time	Method
The proportion of men with clinically insignificant cancer	Within 1 month after the biopsy	The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 1
The proportion of men who do not undergo biopsy	Within 1 month after the biopsy	The proportion of men who do not need for further biopsy in this trial
The proportion of men with adverse events after the intervention	Within 1 week after the biopsy	Any of the adverse events during the trial

Trial Locations

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China