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

NCT03823001 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-05-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Lee Ponsky · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-03-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823001 on ClinicalTrials.gov