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New imaging tech listens to radiation to improve prostate cancer treatment

NCT ID NCT06465966

Knowledge-focused Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a new imaging method called iRAI that uses sound waves to monitor proton radiation delivery in real time for prostate cancer patients. Researchers will compare the actual radiation dose measured by iRAI with the planned dose from CT scans. The goal is to see if iRAI can accurately track where the radiation goes, which could help make treatments more precise. About 30 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ionizing-radiation photo acoustic imaging (iRAI) device
What this could lead to
If successful, this could lead to more precise proton radiation delivery for prostate cancer, potentially reducing side effects.
What could go wrong
This is a small, early-stage feasibility study (30 people) focused on imaging accuracy, not treatment outcomes. The technology may not improve patient results or may have technical limitations.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Disease: Prostate cancer * Treatment site: * Prostate or prostate and seminal vesicle * No regional lymph node is involved * Patient's body weight: Patient's body weight is less than 350 lbs to consider the total weight limit that the ProteusONE treatment table and the robotic arm can operate * Treatment volume size: maximum size less than 15 x 15 cm in a cross-section and a thickness less than 20 cm to consider 2D transducer matrix size * Provision to sign the consent form and understand the non-invasiveness of iRAI * Patient agreement on tolerance on placing a water bag to acquire iRAI during treatment * Treatment modality: Proton radiation therapy with UFHPTI's ProteusONE gantry using PBS Exclusion Criteria: * A patient who would not be tolerable or will feel nervous due to the sensation and coolness of the ultrasound gel appliedt to skin * A patient with a significant medical implant or hardware in the treatment area * A patient may feel uncomfortable with the modular transducer arrays contacting the skin during treatment. Each transducer array contacts a 15 cm × 15 cm area of skin, and depending on the patient's abdominal size, a minimum of two and a maximum of three such areas may be in contact. This produces a sensation of light pressure on the abdomen - comparable to a light hold on the index finger - lasting for a total of 4 minutes.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Univeristy of Florida Health Proton Therapy Institute

    RECRUITING

    Jacksonville, Florida, 32206, United States

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