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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

High Intensity Focused Ultrasound in Prostate Cancer

Salvage Focal Therapy Via High Intensity Focused Ultrasound (HIFU) in Radiorecurrent Localized Prostate Cancer

High Intensity Focused Ultrasound in Prostate Cancer (NCT06402357) is a Phase 2 interventional studying Prostate Cancer, sponsored by University of Florida. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Prostate Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form obtained from the subject and the subject agrees to comply with all the study-related procedures. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Focal One high intensity focused ultrasound device

Participants will be treated with one session of high intensity focused ultrasound using the Focal One device.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Florida
Gainesville, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06402357), the sponsor (University of Florida), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06402357 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06402357?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06402357?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06402357. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06402357. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.