Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04692675
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mpMRI — DIAGNOSTIC_TEST
    3T endorectal coil MR imaging of the prostate gland

Study Details

Background: Active surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Researchers want to see if multiparametric magnetic resonance imaging (mpMRI) can help improve AS. Objective: To see if mpMRI can improve how people are monitored during AS. Eligibility: Men age 18 and older who have been diagnosed with prostate cancer within the last 2 years. Design: Participants will undergo AS. Their PSA level will be checked once a year via blood test. They will have a digital rectal exam once a year. Participants will have biopsies every 2-3 years. Needles will be put into different parts of the prostate. The needles are guided by ultrasound imaging. Participants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion). MRI-US fusion combines previous MRI images with live ultrasound images. For MRIs, participants will lie on their stomach on the scanner table. A coil may be placed in the rectum. Participants will have a physical exam and medical record review at least every 3 years. Their weight and vital signs will be checked. They will give data about their daily activities, side effects, and symptoms. Every 2-3 years, participants will fill out surveys about their prostate health and quality of life. Participants may give blood, urine, prostate secretion, and saliva samples. The samples will be used for research. Participation will last for as long as the participant does not need actual treatment for his prostate cancer.

Key Dates

Start date
Nov 18, 2022
Status verified
May 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2031

Study Design

Enrollment
508 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: AS + mpMRI
    Active surveillance (AS) with the following: a) Initial PSA and DRE screen; then, PSA screening every 12 months, with DRE every year mpMRI or prostate biopsy is performed; b) Initial mpMRI and then prior to all biopsies; c) Initial systemic prostate biopsy and MRI/US fusion-guided prostate biopsy of all suspicious lesions; then, every 2 years for 5 years and then every 3 years

Primary Outcome Measure

role of mpMRI [ Time Frame: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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