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.
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
Metastatic prostate cancer/locally advanced disease
Previous radiation to the pelvis
Bleeding disorder that is not currently treated and stable with normal INR values greater than 2 and PT, PTT less than or equal to 1.5 times the upper limit of normal value.
Severe immunocompromise with CD4 count of less than 200 in HIV patients and bone marrow transplantation patients and or patients with severe combined immunodeficiency.
Single group
mpMRI
Diagnostic test3T endorectal coil MR imaging of the prostate gland
role of mpMRI
role of mpMRI in the selection and management of patients for AS by correlating imaging findings with pathological progression as determined on serial biopsies
correlation of mpMRI, prostate biopsy pathology results, and progression
relationship between mpMRI, prostate biopsy pathology results, and progression in AS patients to determine if prostate biopsies may be safely avoided based on the accuracy of imaging (sensitivity and specificity) to avoid progression
optimal interval of MR imaging
optimal interval of MR imaging in monitoring AS patients for evidence of progression by correlating sequential MRIs with biopsies with the goal to reduce unnecessary imaging
prediction of biopsy findings
determine if MR imaging is superior to PSA and digital rectal exam (DRE) in predicting biopsy findings of progression in AS patients
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