High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 85
View:
• 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
Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Michelle C Cardenas, MSN, NP
mccardenas@mednet.ucla.edu
(310) 794-3070
Backup
Ankush sachdeva
ASachdeva@mednet.ucla.edu
310-794-7700
Time Frame
Start Date: 2018-09-26
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles