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

Study Overview
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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

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: biparametric MRI (bpMRI)
* Diagnostic Test: Prostate cancer antigen (PSA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years old life-expectancy at least 10 years fully understand the clinical trial protocol and sign the informed consent; Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, screen, bpMRI, PSA