HIFU for Focal Ablation of Prostate Tissue: An Observational Study

NCT03620786 | Recruiting FDA Device

• 1 other identifier: 16-000904
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oncological Response

  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 Outcomes (3)

• Evaluation of Quality-of-Life Symptoms (EPIC-CP)

  6 months

• Evaluation of Quality-of-Life Symptoms (EPIC-CP)

  18 months

• Decisional Regret Scale

  18 months

Study Arms (1)

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

Interventions

Sonablate HIFU device 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.

HIFU Study Participants

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 40 years to 85 years
• 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)
• PSA ≤ 20
• Prostate volume of ≤ 70 cc
• Ability to complete informed consent form

You may not qualify if:

• Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
• Medical contraindication to follow-up mpMRI or prostate biopsy
• Unable to tolerate general or regional anesthesia
• 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.)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Leonard Marks, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle C Cardenas, MSN, NP

CONTACT

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

Ankush sachdeva

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 8, 2018
• Study Start: September 26, 2018
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)