RecruitingNot ApplicableNCT04692675

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


Sponsor

National Cancer Institute (NCI)

Enrollment

508 participants

Start Date

Nov 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses advanced MRI imaging to closely monitor low-risk prostate cancer in men who choose active surveillance (watchful waiting instead of immediate treatment), to see whether MRI findings can predict when the cancer is progressing and needs treatment. **You may be eligible if...** - You are a male aged 18 or older - You have biopsy-confirmed prostate adenocarcinoma diagnosed within the past 2 years - Your cancer is low-risk (Gleason score 6 or 3+4=7 with primary pattern 3) - Your clinical stage is T1c or T2a (localized, not yet spreading) - You are enrolled in or eligible for active surveillance **You may NOT be eligible if...** - Your Gleason score is higher than 3+4=7 - Your cancer is more advanced (T2b or higher) - You are not able or willing to undergo regular MRI scans Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTmpMRI

3T endorectal coil MR imaging of the prostate gland


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04692675


Related Trials