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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Lourdes Guallpa contact

352-392-0510

lguallpa@ufl.edu

United States1 site, 1 recruiting

  • University of Florida

    Gainesville, Florida, 32608

    Lourdes Guallpa, 352-392-0510, lguallpa@ufl.edu

    Tarik Benidir, MD

    Recruiting

Other trials in United States

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 groups in NCT06402357
Study groupRoleWhat they receive
High Intensity Focused UltrasoundExperimentalNot 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Time from HIFU to whole gland or systemic therapy

    Determine the time from HIFU to whole gland or systemic therapy

    Measured: 3 years

  8. 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.

  1. First posted7 May 2024
  2. Study start14 May 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lourdes Guallpa (352-392-0510, lguallpa@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-field failure-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06402357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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