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

Primary Purpose

Prostate Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

virtual biopsy (VB) monitoring protocol

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Magnetic Resonance Imaging (MRI)

Eligibility Criteria

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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.

Sites / Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual prostate biopsy (VB) monitoring

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03823001

First Posted

January 28, 2019

Last Updated

May 16, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03823001

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

low accrual

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Magnetic Resonance Imaging (MRI)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual prostate biopsy (VB) monitoring

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

virtual biopsy (VB) monitoring protocol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)

Description

Time Frame

Up to 3 years from start of study

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lee Ponsky

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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