Recruiting

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

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What is being tested

Focal One high intensity focused ultrasound device

Device
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorUniversity of Florida
Study ContactPriya Gurjar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 14, 2025

Actual date on which the first participant was enrolled.

This study is investigating a treatment option called focal therapy using High Intensity Focused Ultrasound (HIFU) for men who have localized prostate cancer that has returned after radiation therapy. Typically, focal therapy is popular because it tends to have fewer side effects compared to more extensive treatments. HIFU has shown good results in patients with varying risks of prostate cancer, but there is not much information on its effectiveness for those whose cancer has returned after radiation. The researchers aim to gather more information about how well focal HIFU works in these cases, especially since many previous studies didn't use the latest imaging techniques which could help better identify and treat the cancer. In this study, participants will receive the focal HIFU treatment, which uses high-energy sound waves to target and destroy cancer cells in a specific area of the prostate without affecting the entire gland. The treatment is applied directly to the prostate and aims to minimize damage to surrounding healthy tissue. The study will evaluate both the cancer control and the impact on urinary and sexual function, as these are important considerations for patients. By focusing on how effective and safe focal HIFU is for treating recurrent prostate cancer, the study hopes to improve treatment options for those affected by this condition.

Official TitleSalvage Focal Therapy Via High Intensity Focused Ultrasound (HIFU) in Radiorecurrent Localized Prostate Cancer
NCT06402357
Principal SponsorUniversity of Florida
Study ContactPriya Gurjar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

10 inclusion criteria required to participate
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

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14 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Florida

Gainesville, United StatesOpen University of Florida in Google Maps
Recruiting
One Study Center