Recruiting

HIFU

Sponsor:

UCLA

Code:

NCT03620786

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Sonablate HIFU device

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT03620786

Start date

Sep 26, 2018

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Oncological Response [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Michelle C Cardenas, MSN, NP

(310) 794-3070mccardenas@mednet.ucla.edu

Ankush sachdeva

310-794-7700ASachdeva@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Leonard Marks, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-16.