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

NCT ID: NCT05025527

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-01

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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bpMRI

Man receive the bpMRI for Prostate cancer(PCa) screening

Group Type EXPERIMENTAL

biparametric MRI (bpMRI)

Intervention Type 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

PSA

Man receive the PSA blood test for Prostate cancer screening

Group Type ACTIVE_COMPARATOR

Prostate cancer antigen (PSA)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haifeng Wang

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital,Tongji University School of Medicine

Locations

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Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Biming He

Role: CONTACT

+8615502139410

Haifeng Wang

Role: CONTACT

+8613681750891

Other Identifiers

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2021076

Identifier Type: -

Identifier Source: org_study_id

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