MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
Stopped early · Not applicable
Conditions studied: Prostate Cancer, Prostate Adenocarcinoma, Multiparametric MRI, Gleason's Score 6
In brief
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.
Key facts
- Study ID
- NCT02564549
- Run by
- Virginia Commonwealth University
- People needed
- 28
- Starts
- 2015-10-05
- Expected to finish
- 2017-10-13
- Last updated by the study team
- 2017-10-19
Who can join
Age: 40 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hunter Holmes Mcguire Veteran Affairs Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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