Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

Description

The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.

Conditions

Prostate Cancer Screening

Study Overview

Study Details

Study overview

The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.

A Phase 3, Multicenter, International, Non-inferiority, Randomized Clinical Trial Comparing Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging (MUSIC-Screen)

Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

Condition
Prostate Cancer Screening
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles (UCLA), Los Angeles, California, United States, 90095

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male sex;
  • 2. Age 50-70;
  • 3. PSA 3-20 and/or abnormal DRE;
  • 4. Biopsy naïve.
  • 1. Prior personal history of prostate cancer;
  • 2. Prior prostate imaging using microUS or MRI;
  • 3. Contraindication to microUS or MRI;
  • 4. Testosterone replacement therapy within last 12 months; or
  • 5. Androgen deprivation therapy within last 12 months.

Ages Eligible for Study

50 Years to 70 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alberta,

Study Record Dates

2029-11-30