New scan could sharpen prostate cancer detection
NCT ID NCT07164027
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early trial is testing whether a special PET/CT scan using flotufolastat F-18 can better guide prostate biopsies than standard MRI. The study will enroll 30 men with suspicious MRI findings. Researchers will compare how often the new method detects aggressive prostate cancer versus the usual approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flotufolastat F-18 (a radioactive tracer used in PET/CT scans)
- What this could lead to
- If successful, this imaging method could help doctors find aggressive prostate cancers more accurately, reducing unnecessary biopsies and improving treatment decisions.
- What could go wrong
- This is a very early (Phase 1) study with only 30 men, so results may not apply to everyone. The new scan might not prove better than current MRI-guided biopsy.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jan 2037
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 to 90 years
- 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: * Men aged 18-90 at study enrollment * Have at least one PI-RADS 3-5 lesion on MRI within the 12 months prior to enrollment Exclusion Criteria: * Contraindication to flotufolastat F 18 PET CT * Contraindication to ultrasound-guided prostate biopsy * Previous treatment of prostate cancer * Unable to discontinue blood thinners for 7 days prior to biopsy * Any investigational agents within 42 days prior to the day of the first dose * Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)
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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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UCLA / Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can brain waves predict bladder control after prostate surgery?
- 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