Back to resultsUse of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate Biopsy, Targeted Biopsy
Eligibility Criteria
Inclusion Criteria:
- No previous diagnosis of adenocarcinoma of the prostate
- No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
- Active urinary tract infection
Exclusion Criteria:
- Prior pelvic radiotherapy
- Prior androgen deprivation therapy
- Evidence urinary tract infection or significant urinary retention
- Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
- Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)
Sites / Locations
- NYU Smilow Prostate Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Targeted Biopsy
Arm Description
Men being evaluated for prostate cancer based upon standard of care clinical parameters (e.g. elevated PSA levels, abnormal DRE, mpMRI) will be considered for enrollment. Men who have undergone prostate mpMRI that has revealed an area(s) of suspicion for prostate cancer are eligible for enrollment. All men enrolled in the study undergo fusion targeted biopsy, visual estimation biopsy, and systematic biopsy. As a result the study includes a single arm with direct comparison of biopsy techniques.
Outcomes
Primary Outcome Measures
Evaluation of rates of prostate cancer diagnosis
The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.
Secondary Outcome Measures
Evaluation of Rate of cancer diagnosis using targeted biopsy
The secondary endpoint of the study is the evaluation of the rate of cancer diagnosis using targeted biopsy (software or cognitive targeting) as compared to standard of care prostate biopsy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01964638
Brief Title
Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
Official Title
Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Prostate Biopsy, Targeted Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Biopsy
Arm Type
Other
Arm Description
Men being evaluated for prostate cancer based upon standard of care clinical parameters (e.g. elevated PSA levels, abnormal DRE, mpMRI) will be considered for enrollment. Men who have undergone prostate mpMRI that has revealed an area(s) of suspicion for prostate cancer are eligible for enrollment. All men enrolled in the study undergo fusion targeted biopsy, visual estimation biopsy, and systematic biopsy. As a result the study includes a single arm with direct comparison of biopsy techniques.
Intervention Type
Procedure
Intervention Name(s)
Targeted Biopsy
Primary Outcome Measure Information:
Title
Evaluation of rates of prostate cancer diagnosis
Description
The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.
Time Frame
One week after biopsy
Secondary Outcome Measure Information:
Title
Evaluation of Rate of cancer diagnosis using targeted biopsy
Description
The secondary endpoint of the study is the evaluation of the rate of cancer diagnosis using targeted biopsy (software or cognitive targeting) as compared to standard of care prostate biopsy.
Time Frame
One week after biopsy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No previous diagnosis of adenocarcinoma of the prostate
No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
Active urinary tract infection
Exclusion Criteria:
Prior pelvic radiotherapy
Prior androgen deprivation therapy
Evidence urinary tract infection or significant urinary retention
Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samr S Taneja, MD
Organizational Affiliation
Co-Director, Smilow Comprehensive Prostate Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Smilow Prostate Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
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