High-intensity Focused Ultrasound Study

High-intensity Focused Ultrasound Study
Lay title: An Observational Study to Learn More About Using High-Intensity Focused Ultrasound for the Removal of Prostate Tissue

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

Disease Type:Prostate Cancer

Basic Information:The purpose of this observational research study is to collect and analyze clinical data from patients before and after receiving HIFU (High Intensity Focused Ultrasound). HIFU is an FDA-approved tool used to ablate prostate tissue. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015.

Research Procedures (not a complete list): Upon obtaining subjects’ informed consent to participate in the study, they will agree to the collection of clinical data for research purposes, and be asked to complete optional pre- and post-treatment questionnaires about quality-of-life data and decision-making.  

Eligibility Criteria (not a complete list):
Inclusion Criteria:

• Age 40-85.
• Has elected or already undergone HIFU therapy as their prostate cancer treatment and declined alternative treatment (such as active surveillance, radiation therapy, etc.).
• PSA ≤ 20.

Exclusion Criteria:

• Prior treatment for prostate cancer other than androgen deprivation therapy.
• Unable to tolerate anesthesia.
• Unable to complete follow-up MRIs or prostate biopsies.

For More Detailed Information, Contact:

• Leonard Marks, MD, Principal Investigator 
• Merdie Delfin, NP, Study Coordinator, (310) 794-3566