Back to resultsMRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
Primary Purpose
Prostate Cancer, Prostate Adenocarcinoma, Multiparametric MRI
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRUS-guided biopsy
mpMRI with targeted biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring low risk prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
- Gleason score ≤ 6
- PSA < 10 ng/mL
- Completed and documented history and physical addressing all inclusion/exclusion criteria.
Exclusion Criteria:
- A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates.
- Previous MRI imaging of the prostate.
- Prior history of pelvic radiotherapy.
- Prior history of prostatectomy.
- Contraindication to prostate mpMRI (renal failure, hip prosthesis, pacemaker, etc).
- Contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy).
- Patients on testosterone replacement therapy who are unwilling to discontinue.
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements.
- Unable to understand, or unwilling to complete the informed consent process.
Sites / Locations
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1 (TRUS-guided biopsy)
Group 2 (mpMRI with targeted biopsy)
Arm Description
Baseline and annual systematic TRUS-guided biopsy performed as per standard of care by urologists for a total of one baseline diagnostic biopsy and two active surveillance systematic biopsies. mpMRI at the end of the 2nd year with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC. Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30). Patients will be followed, as per standard of care, for any potential infections from biopsies. Annual PSA tests performed as per routine standard of care.
Baseline systematic transrectal ultrasound-guided biopsy performed as per standard of care by urologists. Baseline and annual mpMRI with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC. Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30). Patients will be followed, as per standard of care, for any potential infections from biopsies. Annual PSA tests performed as per routine standard of care.
Outcomes
Primary Outcome Measures
To asses the detection rate of Gleason score ≥ 4+3 in patients with low-risk prostate cancer who undergo transrectal ultrasound (TRUS) biopsy-based active surveillance (Group 1) versus patients who undergo mpMRI-based active surveillance (Group 2).
Secondary Outcome Measures
Percentage of patients in Group 1 versus Group 2 who remain on active surveillance from the time of randomization until the end of study participation.
To compare adherence with active surveillance requirements in Group 1 versus Group 2.
To compare the rate of biopsy-related infections in Group 1 versus Group 2.
To compare the missed rate of occult Gleason score ≥ 4+3 by template biopsy at end of study in Group 1 versus Group 2.
Full Information
NCT ID
NCT02564549
First Posted
September 28, 2015
Last Updated
October 17, 2017
Sponsor
Virginia Commonwealth University
Collaborators
Massey Cancer Center, Hunter Holmes Mcguire Veteran Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02564549
Brief Title
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
Official Title
Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
June 28, 2016 (Actual)
Study Completion Date
October 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Massey Cancer Center, Hunter Holmes Mcguire Veteran Affairs Medical Center
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
Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleason's Score 6, but no prior MRI imaging of the prostate.
Detailed Description
This is an unblinded, randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance. Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Multiparametric MRI, Gleason's Score 6
Keywords
low risk prostate cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (TRUS-guided biopsy)
Arm Type
Active Comparator
Arm Description
Baseline and annual systematic TRUS-guided biopsy performed as per standard of care by urologists for a total of one baseline diagnostic biopsy and two active surveillance systematic biopsies.
mpMRI at the end of the 2nd year with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.
Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).
Patients will be followed, as per standard of care, for any potential infections from biopsies.
Annual PSA tests performed as per routine standard of care.
Arm Title
Group 2 (mpMRI with targeted biopsy)
Arm Type
Experimental
Arm Description
Baseline systematic transrectal ultrasound-guided biopsy performed as per standard of care by urologists.
Baseline and annual mpMRI with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.
Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).
Patients will be followed, as per standard of care, for any potential infections from biopsies.
Annual PSA tests performed as per routine standard of care.
Intervention Type
Procedure
Intervention Name(s)
TRUS-guided biopsy
Intervention Description
Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.
Intervention Type
Procedure
Intervention Name(s)
mpMRI with targeted biopsy
Intervention Description
Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.
Primary Outcome Measure Information:
Title
To asses the detection rate of Gleason score ≥ 4+3 in patients with low-risk prostate cancer who undergo transrectal ultrasound (TRUS) biopsy-based active surveillance (Group 1) versus patients who undergo mpMRI-based active surveillance (Group 2).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage of patients in Group 1 versus Group 2 who remain on active surveillance from the time of randomization until the end of study participation.
Description
To compare adherence with active surveillance requirements in Group 1 versus Group 2.
Time Frame
3 years
Title
To compare the rate of biopsy-related infections in Group 1 versus Group 2.
Time Frame
3 years
Title
To compare the missed rate of occult Gleason score ≥ 4+3 by template biopsy at end of study in Group 1 versus Group 2.
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
Gleason score ≤ 6
PSA < 10 ng/mL
Completed and documented history and physical addressing all inclusion/exclusion criteria.
Exclusion Criteria:
A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates.
Previous MRI imaging of the prostate.
Prior history of pelvic radiotherapy.
Prior history of prostatectomy.
Contraindication to prostate mpMRI (renal failure, hip prosthesis, pacemaker, etc).
Contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy).
Patients on testosterone replacement therapy who are unwilling to discontinue.
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements.
Unable to understand, or unwilling to complete the informed consent process.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drew Moghanaki, MD, MPH
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes Mcguire Veteran Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
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