Prostate Cancer Clinical Trial
Official title:
Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)
Verified date | October 2017 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 28 |
Est. completion date | October 13, 2017 |
Est. primary completion date | June 28, 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Hunter Holmes Mcguire Veteran Affairs Medical Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Hunter Holmes Mcguire Veteran Affairs Medical Center, Massey Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 3 years | ||
Secondary | 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. | 3 years | |
Secondary | To compare the rate of biopsy-related infections in Group 1 versus Group 2. | 3 years | ||
Secondary | To compare the missed rate of occult Gleason score = 4+3 by template biopsy at end of study in Group 1 versus Group 2. | 3 years |
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