Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer
NCT03823001 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2022-05-20
Summary
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
virtual biopsy (VB) monitoring protocol
1. PSA bi-annually or more often according to the discretion of the urologist. 2. Annual DRE. 3. Visit with the urologist bi-annually. 4. Multi-parametric MRI (mpMRI) every year for 3 years. 5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Lee Ponsky · University Hospitals Cleveland Medical Center
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-31
- Primary Completion
- 2023-03-31
- Completion
- 2023-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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