HIFU for Focal Ablation of Prostate Tissue: An Observational Study



Status:Enrolling by invitation
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 85
Updated:8/10/2018
Start Date:June 26, 2018
End Date:June 30, 2022

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.

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.)
We found this trial at
1
site
University of California at Los Angeles
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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from
Los Angeles, CA
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