Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws, Biopsies, Ultrasound, MRI scans, Physical exams, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools."
- "Their PSA level will be checked once a year via blood test."
- "Participants will have biopsies every 2-3 years."
- "The needles are guided by ultrasound imaging."
- "Participants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion)."
- "For MRIs, participants will lie on their stomach on the scanner table."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a detailed MRI scan can improve monitoring of prostate cancer during active surveillance. Active surveillance means watching the cancer with tests rather than treating it right away. The study is for men age 18 or older diagnosed within the past 2 years whose cancer meets certain limits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are a man age 18 or older.
- A tissue sample showed prostate adenocarcinoma, a type of prostate cancer, within the past 2 years. NCI's lab must confirm this; a new biopsy may be needed.
- Your biopsy shows a Gleason score of 3+4=7 or lower, with pattern 3 as the main pattern. This score describes how abnormal the cancer cells look.
- Your cancer is at clinical stage cT1c or cT2a, an early stage of prostate cancer.
- You can understand and sign a consent form, including your choice to use active surveillance.
- You must also join NCI study 16-C-0010, which involves prostate cancer care and tissue collection.
Who can't join
- Your prostate cancer has spread to nearby areas or distant parts of the body.
- You have had radiation treatment to your pelvis.
- You have a bleeding disorder that does not meet the study's safety rules for a biopsy.
- You have a severely weakened immune system, such as HIV with a CD4 count below 200 or certain conditions linked to bone marrow transplant.
- You have severe hemorrhoids (grade 3 or higher), or past pelvic surgery prevents clear scans or a safe, accurate biopsy.
- You have had cancer treatment aimed at part or all of your prostate.
- You cannot safely have the study MRI, including because of an allergy to contrast dye or kidneys that cannot safely handle it.
- The study doctor finds another medical condition that makes the study procedures unsafe or unsuitable for you.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda