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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05025527
• Other study ID #: 2021076
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2022
• Source: Shanghai East Hospital
• Contact: Biming He
• Phone: +8615502139410
• Email: 190589109[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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
• 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

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	The proportion of men with adverse events after the intervention	Any of the adverse events during the trial	Within 1 week after the biopsy