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

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
biparametric MRI (bpMRI)
Prostate cancer antigen (PSA)
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Prostate Cancer, screen, bpMRI, PSA

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleAccepts 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;

Sites / Locations

  • Shanghai East Hospital, Tongji University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bpMRI

PSA

Arm Description

Man receive the bpMRI for Prostate cancer(PCa) screening

Man receive the PSA blood test for Prostate cancer screening

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
The proportion of men who do not undergo 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
Any of the adverse events during the trial

Full Information

First Posted
August 23, 2021
Last Updated
October 26, 2022
Sponsor
Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05025527
Brief Title
Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
Official Title
Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, screen, bpMRI, PSA

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bpMRI
Arm Type
Experimental
Arm Description
Man receive the bpMRI for Prostate cancer(PCa) screening
Arm Title
PSA
Arm Type
Active Comparator
Arm Description
Man receive the PSA blood test for Prostate cancer screening
Intervention Type
Diagnostic Test
Intervention Name(s)
biparametric MRI (bpMRI)
Intervention Description
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
Intervention Name(s)
Prostate cancer antigen (PSA)
Intervention Description
Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test
Primary Outcome Measure Information:
Title
The proportion of men with clinically significant cancer
Description
The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more
Time Frame
Within 1 month after the biopsy
Secondary Outcome Measure Information:
Title
The proportion of men with clinically insignificant cancer
Description
The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 1
Time Frame
Within 1 month after the biopsy
Title
The proportion of men who do not undergo biopsy
Description
The proportion of men who do not need for further biopsy in this trial
Time Frame
Within 1 month after the biopsy
Title
The proportion of men with adverse events after the intervention
Description
Any of the adverse events during the trial
Time Frame
Within 1 week after the biopsy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biming He
Phone
+8615502139410
Email
190589109@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng Wang
Phone
+8613681750891
Email
446720864@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang
Organizational Affiliation
Shanghai East Hospital,Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Tongji University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee
IPD Sharing Time Frame
Data will become available after publication with no end date

Learn more about this trial

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

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