New imaging agent could help surgeons find hidden prostate cancer
NCT ID NCT04857502
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This early-stage study is testing a radioactive imaging agent called 99mTc-PSMA-I&S in 30 men with prostate cancer who are scheduled for lymph node removal surgery. The goal is to see how well this agent can help surgeons detect cancer that has spread to the lymph nodes during the operation. The study focuses on measuring where the agent goes in the body and comparing it with lab results from removed tissue.
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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Apr 2021
- Expected to finish
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Jun 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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 with PCa (primary or recurrent disease) * Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging * Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT * Men who are scheduled for pelvic LN dissection (PLND) * Men who can provide oral and written informed consent * Men who can comply with study procedures Exclusion Criteria: * Patients who started any PCa treatment between study enrollment and surgery * Technically inaccessible nodal location
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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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- Could a common blood pressure drug help fight prostate cancer?
- 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