Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
National Cancer Institute (NCI)
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.
Description
Background: * Active Surveillance (AS) is a standard approach in the treatment of low and intermediate risk prostate cancer which employs a strategy of monitoring the clinical progression of prostate cancer. * AS utilizes prostate biopsies, prostate specific antigen (PSA), and digital rectal examinations (DRE) as tools to determine clinical progression in prostate cance * This protocol aims to assess an additional tool, multiparametric magnetic resonance imaging (mpMRI) to actively visualize and monitor disease within the prostate in addition to standard instruments used to determine clinical…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
* INCLUSION CRITERIA: * Participants must have confirmed histopathological diagnosis of adenocarcinoma of the prostate within 2 years prior to study entry. Pathologic diagnosis must be confirmed by Laboratory of Pathology, NCI. If archival tissue is unavailable or insufficient for this purpose, a fresh biopsy will be collected. * Biopsy confirmed prostate cancer with Gleason less than or equal to 3+4=7 (primary pattern 3) * Clinical stage: cT1C or cT2A * Adult males, greater than or equal to 18 years old NOTE: Children are excluded because prostate cancer is not common in pediatric population…
Interventions
- Diagnostic TestmpMRI
3T endorectal coil MR imaging of the prostate gland
Location
- National Institutes of Health Clinical CenterBethesda, Maryland