Sound waves take aim at recurrent prostate cancer
NCT ID NCT06402357
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether high intensity focused ultrasound (HIFU) can control prostate cancer that has come back after radiation therapy. About 25 men will receive one session of HIFU using the Focal One device. Researchers will check if the cancer remains absent in the treated area after 12 months and how the treatment affects quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high intensity focused ultrasound (HIFU) delivered via the Focal One device
- What this could lead to
- If successful, this could offer a less invasive option to control prostate cancer that has come back after radiation, potentially avoiding more aggressive treatments.
- What could go wrong
- This is a small, early-phase study with only 25 participants, so results may not apply to everyone. HIFU may not fully eliminate the cancer, and side effects are possible.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2029
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: * Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer * Males who are ≥ 18 years of age * Eastern Cooperative Oncology Group Performance Status of 0-3 * A history of prostate cancer treated with radiation therapy +/- hormone therapy * MRI or prostate-specific membrane antigen (PSMA) PET region of interest (ROI) * Biopsy proven clinically significant prostate cancer (GG2 or above) recurrence within or ipsilateral to the ROI lesion (within 6 months of the MRI/PET). * Contralateral grade group 1 (GG1) prostate cancer disease to the ROI * PSMA PET negative for metastatic disease (within 6 months of the biopsy) * Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included). * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. Exclusion Criteria: * Contraindication to high intensity focused ultrasound (latex allergy, absent rectum, prior rectal fistula or significant rectal surgery making insertion of transrectal probe non-feasible or dangerous.) * Hormone therapy within 6 months of the screening period (Hormone therapy includes oral (relugolix, abiraterone, enzalutamide, apalutamide, darolutamide, casodex) injections (firmagon, Lupron)) * History of Inflammatory Bowel Disease actively treated in last 3 years * Evidence of ≥ cT3 recurrent disease on imaging * Bilateral clinically significant prostate cancer * Presence of brachytherapy seeds still implanted * Presence of fiduciary markers which directly impede the successful treatment of the lesion of concern, as decided upon by the surgeon upon review of imaging * Large Calcification on CT or transrectal ultrasound which, as per the review of the surgeon, limits or hinders a quality high intensity focused ultrasound to the region of interest * Urethral stricture disease that has been active over the last 6 months or required further treatment than clean intermittent catheterization * No prior radiation therapy for prostate cancer * Subjects without a ROI on MRI or PET * Metastatic disease or locally advanced disease (defined by pelvic lymph node involvement or T4 disease) on PSMA PET * History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
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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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University of Florida
RECRUITINGGainesville, Florida, 32608, 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?