MRI Based Active Selection for Treatment Trial

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT02242773
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
35 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Multi-Parametric MRI — DEVICE
    Multi-Parametric MRI
  • MRI-Guided Biopsy — DEVICE
    MRI-Guided Biopsy

Study Details

The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.

Key Dates

Start date
Nov 12, 2014
Status verified
Jun 2025
Primary completion
May 22, 2024
Completion
May 22, 2024

Study Design

Enrollment
208 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active Surveillance
    Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up.

Primary Outcome Measure

Rate of Disease Progression Within the First Two Surveillance Biopsies [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

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