RightFit
RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 70 Years
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares detailed ultrasound (microUS) with MRI scans to look at the prostate and help decide if a biopsy (a small tissue sample) is needed. It is for men ages 50–70 with a PSA blood test result of 3–20, an abnormal prostate exam, or both, who have never had a prostate biopsy. Participants are placed into one of the two scan groups by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Male.
  • Age 50–70.
  • PSA blood test result of 3–20, an abnormal prostate exam done with a finger through the rectum, or both.
  • Have never had a prostate biopsy (a small tissue sample taken for testing).

Who can't join

  • Have had prostate cancer.
  • Have had a prostate scan using microUS or MRI.
  • Have a medical reason that prevents you from safely having microUS or MRI.
  • Have used testosterone replacement treatment in the past 12 months.
  • Have had treatment to lower or block male hormones, such as testosterone, in the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Male sex; 2. Age 50-70; 3. PSA 3-20 and/or abnormal DRE; 4. Biopsy naïve. Exclusion Criteria: 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.

Study sites (2)

CA

TX