HIFU for Focal Ablation of Prostate Tissue: An Observational Study

April 13, 2026 updated by: Leonard S. Marks, M.D., University of California, Los Angeles

High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance

The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This observational study will serve to collect data from medical record review and questionnaires before and after High Intensity Focused Ultrasound (HIFU) for focal ablation of prostate tissue. The subject will have already undergone or opted to receive the HIFU procedure as part of standard of care in order to participate in this study.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Leonard Marks, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the HIFU procedure as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study.

Description

Inclusion Criteria:

  1. Age 40 years to 85 years
  2. Subject has elected or already undergone HIFU therapy as their standard of care treatment methodand declined alternative treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
  3. PSA ≤ 20
  4. Prostate volume of ≤ 70 cc
  5. Ability to complete informed consent form

Exclusion Criteria:

  1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
  2. Medical contraindication to follow-up mpMRI or prostate biopsy
  3. Unable to tolerate general or regional anesthesia
  4. Positive bone scan (only if bone scan has been done or clinically indicated. Bone scan does not need to be performed for study eligibility determination.)

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIFU Study Participants
Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the HIFU procedure as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study. The HIFU device currently used in this standard-of-care procedure at UCLA is the Sonablate 450 HIFU System.
Device: Sonablate HIFU device
In this study, we will be using the Sonablate 450 HIFU System. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015. HIFU is an example of focal therapy, where the intervention involves targeting diseased areas of prostate tissue, while preserving healthy prostate tissue and minimizing damage to surrounding structures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological Response
Time Frame: 6 months

The following definitions will be used for evaluation of oncological response:

  1. Complete response: Ablation of prostate tissue in targeted biopsy cores at 6 months and 18 months post-procedure biopsy and resolution of initial mp-MRI abnormality.
  2. Incomplete radiographic response: Residual mp-MRI abnormality at 6 months compared to baseline
  3. Local failure: Failure to ablate prostate tissue
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Quality-of-Life Symptoms (EPIC-CP)
Time Frame: 6 months
The EPIC-CP questionnaire will be used to evaluate urinary, bowel and sexual health quality-of-life symptoms for participants pre- and post-HIFU.
6 months
Evaluation of Quality-of-Life Symptoms (EPIC-CP)
Time Frame: 18 months
The EPIC-CP questionnaire will be used to evaluate urinary, bowel and sexual health quality-of-life symptoms for participants pre- and post-HIFU.
18 months
Decisional Regret Scale
Time Frame: 18 months
This questionnaire data will be collected to assess for subjects' decision-making satisfaction.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Leonard Marks, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2018

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-000904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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