Status:
WITHDRAWN
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief 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) particip...
Eligibility Criteria
Inclusion
- Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
- Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
- Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).
Exclusion
- Positive DRE;
- PSA \> 10 ng/ml or unstable PSA (doubling time \<3 years) during the last year prior to enrolling in this study;
- PSAD \> 0.15 (calculated using most recent PSA divided by MRI prostate volume);
- First degree relative diagnosed with prostate cancer
- First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
- Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03823001
Start Date
October 1 2022
End Date
June 1 2023
Last Update
May 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106