Can MRI replace unnecessary biopsies for prostate cancer patients?
NCT ID NCT04692675
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 11 times
Summary
This study looks at whether a special MRI scan (mpMRI) can better monitor prostate cancer in men who choose active surveillance instead of immediate treatment. About 500 men with low-risk prostate cancer will get regular MRIs, biopsies, and blood tests over several years. The goal is to see if MRI can accurately detect cancer growth and possibly reduce the need for repeat biopsies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- multiparametric magnetic resonance imaging (mpMRI)
- What this could lead to
- If successful, this could show that mpMRI helps doctors better track prostate cancer progression, potentially reducing the need for frequent biopsies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not change current practice, and results depend on how well imaging matches biopsy findings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 508 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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