Back to resultsNon-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Primary Purpose
Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cognitive fusion targeted biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, cognitive fusion targeted biopsy, software-based fusion targeted biopsy
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- PSA increase to 4-20 ng/ml and/or abnormal DRE;
- First time to recive prostate biopsy
- Sign the informed consent
Exclusion Criteria:
- Have a prostate biopsy before
- Have acute or chronic prostatitis
- Contraindications to prostate biopsy
- Contraindications to MRI
- Other reasons that not suitable for this 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
cognitive targeted biopsy
software targeted biopsy
Arm Description
a novel three-dimensional matrix positioning based cognitive fusion targeted biopsy combined with a standard 20-region template guided biopsy
software-based fusion targeted biopsy combined with a standard 20-region template guided biopsy
Outcomes
Primary Outcome Measures
The detection rate of clinically significant prostate cancer for targeted biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Secondary Outcome Measures
The detection rate of any prostate cancer for targeted biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
The detection rate of clinically significant prostate cancer for combined biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples
The detection rate of any prostate cancer for combined biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples
Prostate volume
To measure the prostate volume by ultrasound and MRI
Full Information
NCT ID
NCT04271527
First Posted
February 13, 2020
Last Updated
October 26, 2022
Sponsor
Shanghai East Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04271527
Brief Title
Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Official Title
Non-inferiority Randomized Controlled Trial of Novel Three-dimensional Matrix Positioning Based Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 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 randomized controlled and non-inferiority trial in comparison of the novel three-dimensional matrix positioning cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy.
Detailed Description
This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether a novel three-dimensional matrix positioning cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, cognitive fusion targeted biopsy, software-based fusion targeted biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
602 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cognitive targeted biopsy
Arm Type
Experimental
Arm Description
a novel three-dimensional matrix positioning based cognitive fusion targeted biopsy combined with a standard 20-region template guided biopsy
Arm Title
software targeted biopsy
Arm Type
Active Comparator
Arm Description
software-based fusion targeted biopsy combined with a standard 20-region template guided biopsy
Intervention Type
Procedure
Intervention Name(s)
cognitive fusion targeted biopsy
Intervention Description
A novel three-dimensional matrix positioning based cognitive fusion targeted biopsy
Primary Outcome Measure Information:
Title
The detection rate of clinically significant prostate cancer for targeted biopsy
Description
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Time Frame
5-6 weeks after signing the consent
Secondary Outcome Measure Information:
Title
The detection rate of any prostate cancer for targeted biopsy
Description
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
Time Frame
5-6 weeks after signing the consent
Title
The detection rate of clinically significant prostate cancer for combined biopsy
Description
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples
Time Frame
5-6 weeks after signing the consent
Title
The detection rate of any prostate cancer for combined biopsy
Description
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples
Time Frame
5-6 weeks after signing the consent
Title
Prostate volume
Description
To measure the prostate volume by ultrasound and MRI
Time Frame
5-6 weeks after signing the consent
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 18
PSA increase to 4-20 ng/ml and/or abnormal DRE;
First time to recive prostate biopsy
Sign the informed consent
Exclusion Criteria:
Have a prostate biopsy before
Have acute or chronic prostatitis
Contraindications to prostate biopsy
Contraindications to MRI
Other reasons that not suitable for this trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biming He, MD
Phone
+8615502139410
Email
190589109@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng Wang, MD
Phone
+8613681750891
Email
446720864@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang, MD
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biming He, MD
Phone
+8615502139410
Email
190589109@qq.com
First Name & Middle Initial & Last Name & Degree
Haifeng Wang, MD
Phone
+8613681750891
Email
446720864@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33550242
Citation
He B, Li R, Li D, Huang L, Wen X, Yang G, Wang H. Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy. BMJ Open. 2021 Feb 5;11(2):e041427. doi: 10.1136/bmjopen-2020-041427.
Results Reference
derived
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Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
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