Prostate CancerNCT02564549
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
A study testing TRUS-guided biopsy and mpMRI with targeted biopsy in people with Prostate Cancer and Prostate Adenocarcinoma, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Multiparametric MRI
- What is being tested?
- TRUS-guided biopsy and mpMRI with targeted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2015to 13 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes Mcguire Veteran Affairs Medical Center
Richmond, Virginia, 23249
About this study
Official title: Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)
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.
Read the 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.
- Being tested
- TRUS-guided biopsy, mpMRI with targeted biopsy
- Keywords
- low risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUS-guided biopsyProcedure or surgery
Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.
mpMRI with targeted biopsyProcedure or surgery
Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TRUS-guided biopsy) | Active comparator | * 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. Receives: Procedure: TRUS-guided biopsy |
| Group 2 (mpMRI with targeted biopsy) | Experimental | * 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. Receives: Procedure: mpMRI with targeted biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
To compare the rate of biopsy-related infections in Group 1 versus Group 2.
Measured: 3 years
To compare the missed rate of occult Gleason score ≥ 4+3 by template biopsy at end of study in Group 1 versus Group 2.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start5 Oct 2015
- Primary completion28 Jun 2016
- Study completion13 Oct 2017
Why it stopped: Study halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Massey Cancer Center, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Drew Moghanaki, MD, MPH, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564549
- Sponsor's protocol ID
- MCC-14-10633
- Other IDs
- NCI-2015-01739, 02147
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)
- ClinicalTrials.gov ID
- NCT02564549
- Acronym / sponsor ID
- MCC-14-10633
- Keywords
- low risk prostate cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Massey Cancer Center, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (TRUS-guided biopsy) | Active comparator | Procedure: TRUS-guided biopsy* 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. |
| Group 2 (mpMRI with targeted biopsy) | Experimental | Procedure: mpMRI with targeted biopsy* 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRUS-guided biopsyPatients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. | Procedure or surgery | Group 1 (TRUS-guided biopsy) |
| mpMRI with targeted biopsyPatients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings. | Procedure or surgery | Group 2 (mpMRI with targeted biopsy) |
Primary outcome
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
3 secondary outcomes
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.
Time frame: 3 years
To compare the rate of biopsy-related infections in Group 1 versus Group 2.
Time frame: 3 years
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
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drew Moghanaki, MD, MPH principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUS-guided biopsy and mpMRI with targeted biopsy in people with Prostate Cancer and Prostate Adenocarcinoma, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.