HIFU for Focal Ablation of Prostate Tissue: An Observational Study
High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
About This Trial
- This study tracks how well a treatment that uses focused sound waves to destroy targeted prostate cancer tissue works and how it affects everyday quality of life.
- It is open to men between the ages of 40 and 85 with localized prostate cancer who have already chosen or received this ultrasound therapy instead of surgery or radiation.
- To qualify, patients must have a moderate prostate-specific antigen (PSA) level, a suitable prostate size, and no history of other major prostate cancer treatments.
- Because this is an observational study, joining will not change your medical care, but you should know that you will need to fill out health surveys and be able to undergo routine follow-up scans and biopsies.
More Information
- 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.
Who Can Enroll
- Age Range: 40 - 85 years
- Gender: Male
- Who This Trial is For: This study tracks how well a treatment that uses focused sound waves to destroy targeted prostate cancer tissue works and how it affects everyday quality of life.
Study Details
- Start Date: September 26, 2018
- Lead Sponsor: University of California, Los Angeles
Full Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.)
Treatments
- Device: Sonablate HIFU device