HIFU for Focal Ablation of Prostate Tissue: An Observational Study
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT03620786
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 40 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sonablate HIFU device — DEVICEIn 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.
Study Details
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.
Key Dates
- Start date
- Sep 26, 2018
- Status verified
- Apr 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: HIFU Study ParticipantsSubjects 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.
Primary Outcome Measure
Oncological Response [ Time Frame: 6 months ]
Central Contacts
- Michelle C Cardenas, MSN, NP(310) 794-3070
- Ankush sachdeva310-794-7700
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | Leonard Marks, MD (PRINCIPAL_INVESTIGATOR) |
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