Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT04692675

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

Loading map...

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