AI vs. radiologist: who spots prostate cancer better?
NCT ID NCT07084779
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study looks at whether artificial intelligence (AI) can help radiologists find prostate cancer on MRI scans. About 150 men aged 55-80 who are scheduled for a prostate biopsy will take part. The AI software will be compared to radiologists reading the scans alone. The goal is to see if AI improves detection of significant cancers, but this study does not test a new treatment.
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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 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2026
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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55 to 80 years
- Sex
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Anyone
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Plan of care is to undergo a biopsy of the prostate after a pre-biopsy MRI * Age 55-80 * Prostate-specific antigen (PSA) between 3-10 ng/mL * No prior diagnosis or treatment of prostate cancer Exclusion Criteria: * Pre-biopsy MRI is of low quality * PI-QUAL score of 1 using PI-QUAL version 2
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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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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?