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High Intensity Focused Ultrasound for Radiorecurrent Prostate Cancer

This study is looking at how well a treatment called high intensity focused ultrasound (HIFU) works for men with prostate cancer that has come back after radiation therapy. You would receive one session of HIFU using a device called Focal One. The study aims to see how long men stay free from their cancer returning in the treated area after 12 months, and also how their quality of life changes after the treatment. To join, you must be a man at least 18 years old who has already had radiation therapy for prostate cancer and has chosen to have focal HIFU. The study is planning to enroll 25 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 25 participants. It will evaluate a single treatment with the Focal One high intensity focused ultrasound device.
What's involved
Participants will undergo one session of high intensity focused ultrasound therapy. The record does not specify other visits, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants stay free from cancer returning in the treated area for 12 months after treatment.

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NCT06402357

High Intensity Focused Ultrasound in Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Florida
~25 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Focal One high intensity focused ultrasound device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
In-field failure-free survival
Measured over 12 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Tarik Benidir, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Lourdes Guallpa
[email protected]
352-392-0510
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • In-field failure-free survival12 months

    Evaluate the in-field failure-free survival (IFFFS) of localized radiorecurrent prostate cancer patients receiving focal HIFU treatment at 12 months. IFFFS is defined as the absence of biopsy proven clinically significant prostate cancer in the treated zone.