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

Tongji University

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Prostate cancer antigen (PSA); Diagnostic Test: biparametric MRI (bpMRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05025527

2021076

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

bpMRI

Experimental group

Description:

Man receive the bpMRI for Prostate cancer(PCa) screening

Treatment:

Diagnostic Test: biparametric MRI (bpMRI)

PSA

Active Comparator group

Description:

Man receive the PSA blood test for Prostate cancer screening

Treatment:

Diagnostic Test: Prostate cancer antigen (PSA)