RecruitingObservational

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

NCT ID: NCT03620786Sponsor: University of California, Los AngelesLast updated: 2026-04-16

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.

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.

Arms & interventions

DeviceSonablate 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.

Outcome measures

Primary

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
Time frame: 6 months

Secondary

Evaluation of Quality-of-Life Symptoms (EPIC-CP)
Time frame: 6 months
Evaluation of Quality-of-Life Symptoms (EPIC-CP)
Time frame: 18 months
Decisional Regret Scale
Time frame: 18 months

Eligibility criteria

Sex: MaleAge: 40 Years to 85 Years

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 locations (1)

University of California, Los Angeles

Los Angeles, California, 90095

Recruiting

Leonard Marks, MD · Principal Investigator