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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: biparametric MRI (bpMRI); Diagnostic test: Prostate cancer antigen (PSA)

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Biming He; Phone Number: +8615502139410; Email: 190589109@qq.com
• Study Contact Backup: Name: Haifeng Wang; Phone Number: +8613681750891; Email: 446720864@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital, Tongji University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bpMRI; Man receive the bpMRI for Prostate cancer(PCa) screening	Diagnostic test: biparametric MRI (bpMRI); Men go for the bpMRI for PCa (prostate cancer) screening, those who had a suspicious result will go for the next confirmation test
Active Comparator: PSA; Man receive the PSA blood test for Prostate cancer screening	Diagnostic test: Prostate cancer antigen (PSA); Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of men with clinically significant cancer	The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more	Within 1 month after the biopsy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: PSA; Prostate Cancer; screen; bpMRI
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2021076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee
• IPD Sharing Time Frame: Data will become available after publication with no end date
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No