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HIFU for Focal Ablation of Prostate Tissue: An Observational Study

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Brief Summary

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.

Study Type
Observational
Phase
Pilot/Feasibility

Eligibility

Gender
Male
Minimum Age
40 Years
Maximum Age
85 Years

Inclusion Criteria:

  • Age 40 years to 85 years
  • 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)
  • PSA ≤ 20
  • Prostate volume of ≤ 70 cc
  • Ability to complete informed consent form

Exclusion Criteria:

  • Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
  • Medical contraindication to follow-up mpMRI or prostate biopsy
  • Unable to tolerate general or regional anesthesia
  • 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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Study Stats
Protocol No.
16-000904
Category
Prostate Cancer
Contact
Merdie Delfin
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03620786
For detailed technical eligibility, visit ClinicalTrials.gov.