Actively Recruiting
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-06
508
Participants Needed
1
Research Sites
458 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of prostate adenocarcinoma within 2 years before study entry confirmed by NCI Laboratory of Pathology
- Biopsy confirmed prostate cancer with Gleason score less than or equal to 3+4=7 (primary pattern 3)
- Clinical stage cT1C or cT2A
- Adult males 18 years or older
- Ability to understand and willingly sign informed consent for active surveillance
- Co-enrollment to NCI protocol 16-C-0010 Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
You will not qualify if you...
- Metastatic or locally advanced prostate cancer
- Previous radiation therapy to the pelvis
- Contraindications to prostate biopsy including untreated bleeding disorders with abnormal INR/PT/PTT, severe immunocompromise (CD4 <200), severe hemorrhoids grade 3 or above, prior pelvic surgery preventing imaging or biopsy
- Prior focal or whole gland prostate therapy for cancer
- Contraindications to mpMRI such as allergy or kidney problems preventing use of contrast agents
- mpMRI evidence of stage T3 or higher disease including seminal vesicle invasion, extraprostatic extension, or locoregional spread
- Any other medical condition deemed by investigators to make participant ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Karen K Holcomb
CONTACT
P
Peter A Pinto, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here