Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Geno… (NCT04692675) | Clinical Trial Compass
RecruitingNot Applicable
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
United States508 participantsStarted 2022-11-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
role of mpMRI
Timeframe: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
2
correlation of mpMRI, prostate biopsy pathology results, and progression
Timeframe: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).
3
optimal interval of MR imaging
Timeframe: beginning of study, prior to all biopsies (i.e., every 2 years until year 5; then, every 3 years after year 5).