HIFU for Focal Ablation of Prostate Tissue: An Observational Study
Status
RECRUITING
Phase
Age
40 - 85 Years
Enrollments
100Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Leonard Marks, MD
Principal Investigator
- Leonard Marks, MD
Eligibility Criteria
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 Plan
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 deviceDescription:
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 Outcome Measures
Oncological Response
Secondary Outcome Measures
Evaluation of Quality-of-Life Symptoms (EPIC-CP)
Evaluation of Quality-of-Life Symptoms (EPIC-CP)
Decisional Regret Scale
Timeline
Last Updated
January 10, 2024Start Date
August 8, 2018Today
February 5, 2025Completion Date ( Estimated )
January 31, 2028
Sponsors of this trial
Lead Sponsor
University of California, Los Angeles
RECRUITING 
21 - 64 Years