← Back to searchRecruitingRecruiting
HIFU for Focal Ablation of Prostate Tissue: An Observational Study
NCT03620786 · University of California, Los Angeles
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
About this study
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.
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 design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2018-09-26
Estimated completion: 2028-01-31
Last updated: 2026-04-16
Interventions
Device: Sonablate HIFU device
Primary outcomes
- • Oncological Response (6 months)
Sponsor
University of California, Los Angeles · other
Contacts & investigators
ContactMichelle C Cardenas, MSN, NP · contact · mccardenas@mednet.ucla.edu · (310) 794-3070
ContactAnkush sachdeva · contact · ASachdeva@mednet.ucla.edu · 310-794-7700
InvestigatorLeonard Marks, MD · principal_investigator, University of California, Los Angeles
All locations (1)
University of California, Los AngelesRecruiting
Los Angeles, California, United States