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

May 16, 2022 updated by: Case Comprehensive Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual prostate biopsy (VB) monitoring

Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:

  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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
Time Frame: Up to 3 years from start of study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Lee Ponsky, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (ACTUAL)

January 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE9818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

To be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

For individual participant data meta-analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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