MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
Prostate Cancer, Prostate Adenocarcinoma, Multiparametric MRI
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
Active Comparator
Experimental
Group 1 (TRUS-guided biopsy)
Group 2 (mpMRI with targeted 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.
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.