High Intensity Focused Ultrasound in Prostate Cancer

NCT06402357 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • EDAP-TMS Focal One

    collaborator UNKNOWN
  • University of Florida

    lead OTHER

Principal Investigators

  • Tarik Benidir, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2027-08-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402357 on ClinicalTrials.gov