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

NCT05025527 | Unknown DMC

• 1 other identifier: 2021076
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; screen; bpMRI; PSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

bpMRI

EXPERIMENTAL

Man receive the bpMRI for Prostate cancer(PCa) screening

Diagnostic Test: biparametric MRI (bpMRI)

PSA

ACTIVE COMPARATOR

Man receive the PSA blood test for Prostate cancer screening

Diagnostic Test: Prostate cancer antigen (PSA)

Interventions

biparametric MRI (bpMRI) DIAGNOSTIC_TEST

Men go for the bpMRI for PCa (prostate cancer) screening, those who had a suspicious result will go for the next confirmation test

bpMRI

Prostate cancer antigen (PSA) DIAGNOSTIC_TEST

Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test

PSA

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Haifeng Wang

  Shanghai East Hospital,Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biming He

CONTACT

+8615502139410; 190589109@qq.com

Haifeng Wang

CONTACT

+8613681750891; 446720864@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after publication with no end date

Locations

CN (1)