Prostate CancerPhase 2NCT06402357
High Intensity Focused Ultrasound in Prostate Cancer
A Phase 2 study testing Focal One high intensity focused ultrasound device in people with Prostate Cancer, run by University of Florida at 1 site in United States.
Trial summary
This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal One high intensity focused ultrasound device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to Aug 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Lourdes Guallpa, 352-392-0510, lguallpa@ufl.edu
Tarik Benidir, MD
About this study
Official title: Salvage Focal Therapy Via High Intensity Focused Ultrasound (HIFU) in Radiorecurrent Localized Prostate Cancer
This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.
Read the detailed description
Focal therapy is increasingly popular due to its minimal side effect profile. Furthermore, HIFU has demonstrated favorable oncologic outcomes in well selected patients, including those with intermediate and high risk disease. In patients with radiorecurrent prostate cancer there remains a paucity of data on the value of focal therapy. Review of focal HIFU rather than whole gland HIFU is based on largely retrospective data and in an era where mpMRI and PSMA PET was not yet widely implemented thus not reflecting the current patient population seeking this care. In fact, and to the investigators' knowledge, only one study has prospectively evaluated focal HIFU therapy in radiorecurrent prostate cancer. Further evaluation into the value of focal HIFU in select men with localized radiorecurrent clinically significant prostate cancer is needed (clinically significant prostate cancer defined as GG2 or above. GG1 prostate cancer will not be considered clinically significant prostate cancer), both in terms of oncologic and functional outcomes as this patient population is increasing.
- Conditions
- Prostate Cancer
- Being tested
- Focal One high intensity focused ultrasound device
- Keywords
- prostate cancer, high intensity focused ultrasound, focal therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal One high intensity focused ultrasound deviceDevice
Participants will be treated with one session of high intensity focused ultrasound using the Focal One device.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Focused Ultrasound | Experimental | Not described Receives: Device: Focal One high intensity focused ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-field failure-free survival
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.
Measured: 12 months
Secondary outcomes (8)
Local failure-free survival
Evaluate the local failure-free survival (LFFS) of localized radiorecurrent prostate cancer patients receiving focal HIFU treatment at 12 months. LFFS is defined as the absence of biopsy proven clinically significant prostate cancer both in and out of the treated zone.
Measured: 12 months
Complication rates
Determine the complication rates (Clavien Dindo >3) within the first 12 months. Complications include urinary tract infection, hematuria, urinary retention, stricture, bladder neck contracture, and incontinence.
Measured: 12 months
Change in quality of life metrics
Determine the change from baseline in the International Prostate Symptom Score questionnaire total score at 6 months after HIFU treatment.
Measured: 6 months
Change in quality of life metrics
Determine the change from baseline in the International Prostate Symptom Score questionnaire total score at 12 months after HIFU treatment.
Measured: 12 months
Change in quality of life metrics
Determine the change from baseline in International Index of Erectile Function questionnaire scores at 6 months after HIFU treatment.
Measured: 6 months
Change in quality of life metrics
Determine the change from baseline in International Index of Erectile Function questionnaire scores at 12 months after HIFU treatment.
Measured: 12 months
Time from HIFU to whole gland or systemic therapy
Determine the time from HIFU to whole gland or systemic therapy
Measured: 3 years
Time from HIFU to androgen deprivation therapy onset
Determine the time from HIFU to androgen deprivation therapy onset
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start14 May 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- EDAP-TMS Focal One
- Responsible party
- Sponsor
- Investigators
- Tarik Benidir, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402357
- Sponsor's protocol ID
- UF-GU-009
- Other IDs
- IRB202401126
- Status last verified
- Jun 2026
- First submitted
- 2 May 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes