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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Alberta
Study ID
NCT06626022
Phase
PHASE3
Status
Recruiting
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Conditions

  • Prostate Cancer Screening

Eligibility Criteria

Sex
MALE
Age
50 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • MRI — DEVICE
    Standard prostate mpMRI.
  • ExactVu — DEVICE
    microUltrasound

Study Details

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.

Key Dates

Start date
May 8, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
1,284 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: MRI
  • Experimental: microUltransound

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles (UCLA)Los AngelesCalifornia90095
Ankush Sachdeva
[email protected]
310-794-3452
Wayne Brisbane, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Sonobia Garrett
[email protected]
214-645-8787
Xiaosong Meng, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, Los Angeles (UCLA)· Los Angeles, CAUT Southwestern Medical Center· Dallas, TX

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