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Recruiting NCT06626022

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

Phase III Interventional Prostate Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI, ExactVu.
Who it may be relevant to
Registry conditions: Prostate Cancer Screening. Basic parameters: 50 years — 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, France, Norway, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

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.

Interventions

  • Device MRI
    Standard prostate mpMRI.
  • Device ExactVu
    microUltrasound

Primary outcome measures

  • Detection of Clinically significant prostate cancer. [Time frame: Once enrolled, men will be followed for 1 year after the imaging test.]

Eligibility criteria

Inclusion criteria

  • Male sex;
  • Age 50-70;
  • PSA 3-20 and/or abnormal DRE;
  • Biopsy naïve.

Exclusion criteria

  • Prior personal history of prostate cancer;
  • Prior prostate imaging using microUS or MRI;
  • Contraindication to microUS or MRI;
  • Testosterone replacement therapy within last 12 months; or
  • Androgen deprivation therapy within last 12 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

Canada · 4 centers
  • University of Alberta — Edmonton
  • University of British Columbia — Vancouver
  • Sunnybrook Health Sciences Centre — Toronto
  • CIUSSS du Nord-de-l'Île-de-Montréal — Montréal
United States · 2 centers
  • University of California, Los Angeles (UCLA) — Los Angeles
  • UT Southwestern Medical Center — Dallas
France · 1 center
  • CH de Martigues — Martigues
Norway · 1 center
  • Vestfold Hospital Trust — Tønsberg
Spain · 1 center
  • Urologia Clinica Bilbao — Bilbao

Publications

  • Guer M, Beksac AT, Brisbane W, Cash H, Ghai S, Ghosh S, Heinrichs A, Klotz L, Lavigueur-Blouin H, Loffeler S, Lughezzani G, Mannas M, Meng X, Morgan TN, Nahar B, Rodrigues T, Struck JP, Tiwari R, Toledano H, Urdaneta F, Kinnaird A. Optimizing prostate biopsy decision making - (MUSIC-screen): A 1:1 randomized controlled trial comparing micro-ultrasound versus multiparametric magnetic resonance imag PMID 42476253

Identifiers

NCT: NCT06626022 · HREBA.CC-24-0325

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗