Open Actively Recruiting

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

About

Brief Summary

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.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Screening
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 3

Eligibility

Gender
Male
Healthy Volunteers
Yes
Minimum Age
50 Years
Maximum Age
70 Years

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.
Study Stats
Protocol No.
25-0089
Category
Prostate Cancer
Principal Investigator
Wayne G. Brisbane, MD
Wayne G. Brisbane, MD
Urologic Oncology, Urology
Wayne G. Brisbane, MD
Contact
  • Keyla Morales
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06626022
For detailed technical eligibility, visit ClinicalTrials.gov.