Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03823001
• Other study ID #: CASE9818
• Status: Withdrawn
• Phase: N/A
• Start date: October 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• virtual biopsy (VB) monitoring protocol
PSA bi-annually or more often according to the discretion of the urologist. Annual DRE. Visit with the urologist bi-annually. Multi-parametric MRI (mpMRI) every year for 3 years. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.

Locations

Country	Name	City	State
United States	University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)	Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.	Up to 3 years from start of study