Can an ultrasound rival MRI for prostate cancer detection?
NCT ID NCT06024772
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This study compares a special ultrasound (mp-US) with contrast dye to standard MRI for finding prostate cancer. About 300 men scheduled for a biopsy will get both scans to see if the ultrasound can guide biopsies just as well as MRI. The goal is to offer a simpler, cheaper option for diagnosis.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Subject must be scheduled for a prostate biopsy, based on an elevated PSA (\> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (\> 0.75ng/ml/year), or abnormal digital rectal examination * Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies * Subject must be a male at least 18 years of age when informed consent is obtained Exclusion Criteria: * Participant in a clinical trial involving an investigational drug within the past 30 days * Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity * Previous treatment for prostate cancer, including hormone therapy * Clinically unstable, severely ill, or moribund as per treating physician
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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
2 sites in 2 countries. 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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Amsterdam Medical Center
Amsterdam-Zuidoost, Netherlands
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer could reveal hidden prostate cancer
- New PET-MRI tracer could sharpen prostate cancer biopsy accuracy
- New PET tracer could spot cancers that standard scans overlook