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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 31, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how a special type of imaging called multiparametric magnetic resonance imaging (mpMRI) can help doctors monitor men with low to intermediate risk prostate cancer who are undergoing a treatment approach known as active surveillance. Active surveillance means that instead of immediate treatment, doctors closely watch the cancer using regular blood tests, physical exams, and biopsies to see if there are any changes. The goal is to find out if mpMRI can provide better information about the cancer and help in making treatment decisions.

To participate in this trial, men aged 18 and older who have been diagnosed with prostate cancer in the last two years may be eligible, as long as their cancer is at an early stage and not spread to other parts of the body. Participants will have regular check-ups, including annual blood tests and biopsies every couple of years, where small tissue samples are taken from the prostate to check for cancer changes. They will also complete surveys about their health and quality of life. The trial will last as long as participants do not need immediate treatment for their cancer.

Gender

MALE

Eligibility criteria

• * 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 populations. Women are not eligible because this disease occurs only in men.
• • Ability of subject to understand and the willingness to sign a written informed consent document All participants should have a consent signed that demonstrates an understanding of active surveillance and the decision to choose active surveillance for their prostate cancer.
• • Subjects must be co-enrolled to NCI protocol 16-C-0010 Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
• EXCLUSION CRITERIA:
• • Metastatic prostate cancer/locally advanced disease
• • Previous radiation to the pelvis
• * Contraindications to prostate biopsy, including:
• • 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.
• • Severe hemorrhoids grade 3 and above
• • Prior surgery in the pelvis that prevents accurate imaging or biopsy including low anterior resection or abdominoperineal resection.
• • Prior focal or whole gland therapy of the prostate for prostate cancer
• • Contraindication to mpMRI, including allergy or sensitivity to contrast agents or insufficient renal function to safely tolerate MRI contrast agent
• • mpMRI evidence of greater than or equal to T3 disease, including seminal vesicle invasion (SVI), extraprostatic extension (EPE) or locoregional spread of disease
• • Any other medical conditions deemed by the PI or associates to make the participants ineligible for protocol procedures