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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: biparametric MRI (bpMRI); Diagnostic Test: Prostate cancer antigen (PSA)

• 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

Arm && Interventions

Group	Intervention	Description
bpMRI	biparametric MRI (bpMRI)	Man receive the bpMRI for Prostate cancer(PCa) screening
PSA	Prostate cancer antigen (PSA)	Man receive the PSA blood test for Prostate cancer screening

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