Trials / Withdrawn
WithdrawnNCT03823001
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer
Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2023-03-01
- Completion
- 2023-06-01
- First posted
- 2019-01-30
- Last updated
- 2022-05-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03823001. Inclusion in this directory is not an endorsement.