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 — DEVICE
    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.

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 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.

Primary Outcome Measure

Oncological Response [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Leonard Marks, MD (PRINCIPAL_INVESTIGATOR)

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