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HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Recruitingn/aAges 40 Years - 85 YearsMaleUniversity of California, Los Angeles
NCT03620786 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.)
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What it tests

  • Sonablate HIFU device
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Where

1 site
University of California, Los Angeles
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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