Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT05220501
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Microultrasonography Targeted Biopsy — DIAGNOSTIC_TEST
    All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
  • MRI Targeted Biopsy — DIAGNOSTIC_TEST
    All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.

Study Details

OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

Key Dates

Start date
Dec 15, 2021
Status verified
Oct 2025
Primary completion
Sep 6, 2024
Completion
Sep 6, 2024

Study Design

Enrollment
804 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Microultrasonography only
    Subjects will undergo biopsy using micro-ultrasound only.
  • Active Comparator: Microultrasonography + MRI
    Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound
  • Active Comparator: MRI + Conventional Ultrasonography
    Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Primary Outcome Measure

Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy [ Time Frame: Post biopsy ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-
Yale UniversityNew HavenConnecticut06511-
University of Florida HealthGainsvilleFlorida32611-
Johns HopkinsBaltimoreMaryland21205-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
UCLA· Los Angeles, CAYale University· New Haven, CTUniversity of Florida Health· Gainsville, FLJohns Hopkins· Baltimore, MDCarolina Urologic Research Center· Myrtle Beach, SC

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