Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artemis™ software system
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score >3/5)
Exclusion Criteria:
- Prior pelvic radiotherapy
- Evidence of urinary tract infection or significant urinary retention
- Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
- No evidence of suspicious lesions on mpMRI
- Irreversible coagulopathy
- Contraindication to sedation
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI Targeted Biopsy
Arm Description
Outcomes
Primary Outcome Measures
Core Cancer Length
Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)
Secondary Outcome Measures
Percentage of High-Grade Prostate Cancer Using Gleason Score
High-grade prostate cancer is defined as a Gleason score > 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.
Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)
Full Information
NCT ID
NCT03366792
First Posted
November 21, 2017
Last Updated
February 24, 2022
Sponsor
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT03366792
Brief Title
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Official Title
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Investigators chose to discontinue the study based on interim findings
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
February 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.
Detailed Description
Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI Targeted Biopsy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Artemis™ software system
Intervention Description
Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
Primary Outcome Measure Information:
Title
Core Cancer Length
Description
Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
Percentage of High-Grade Prostate Cancer Using Gleason Score
Description
High-grade prostate cancer is defined as a Gleason score > 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.
Data is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)
Time Frame
2 Months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score >3/5)
Exclusion Criteria:
Prior pelvic radiotherapy
Evidence of urinary tract infection or significant urinary retention
Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
No evidence of suspicious lesions on mpMRI
Irreversible coagulopathy
Contraindication to sedation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Taneja, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
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