HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Eligibility: for males ages 40-85 (full criteria)
Location: at UCLA
Dates: study started September 2018
completion around January 2028
Principal Investigator: by Leonard S. Marks, MD (ucla)

Leonard S. Marks

Description

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.

Official Title

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

Details

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.

Keywords

Prostate Cancer, Prostatic Neoplasms, Sonablate HIFU device

Eligibility

You can join if…

Open to males ages 40-85

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 CAN'T join 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.)

Location

University of California, Los Angeles accepting new patients
Los Angeles California 90095 United States

Lead Scientist at University of California Health

Leonard S. Marks, MD (ucla)
Dr. Leonard Marks holds the Jean B. deKernion, M.D., Endowed Chair in Urology.

Details

Status: accepting new patients
Start Date: September 2018
Completion Date: January 2028 (estimated)
Sponsor: University of California, Los Angeles
ID: NCT03620786
Study Type: Observational
Participants: Expecting 100 study participants
Last Updated: March 11, 2025