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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05025527

Enrollment

500

Registered

2021-08-27

Start date

2022-12-01

Completion date

2024-12-01

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, screen, bpMRI, PSA

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

Interventions

DIAGNOSTIC_TESTbiparametric 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

DIAGNOSTIC_TESTProstate 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactBiming He

190589109@qq.com+8615502139410

Backup ContactHaifeng Wang

446720864@qq.com+8613681750891

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026