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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02564549 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
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Scientific title:
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Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK) |
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Date of first enrolment:
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October 5, 2015 |
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Target sample size:
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28 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02564549 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Drew Moghanaki, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massey Cancer Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Gleason's Score 6
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Prostate Adenocarcinoma
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Multiparametric MRI
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Prostate Cancer
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Intervention(s)
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Procedure: mpMRI with targeted biopsy
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Procedure: TRUS-guided biopsy
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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To compare the rate of biopsy-related infections in Group 1 versus Group 2.
[Time Frame: 3 years]
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Secondary ID(s)
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MCC-14-10633
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02147
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NCI-2015-01739
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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