HIFU for Focal Ablation of Prostate Tissue: An Observational Study
About this study
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.
- Condition
- Prostate Cancer
- Tested
- Sonablate HIFU device
- Sponsor
- University of California, Los Angeles
Who can join
- Age
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not stated
Inclusion 9
- Minimum age: 40 years
- Maximum age: 85 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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 4
- 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.)
Where
1 site, 1 recruiting
University of California, Los Angeles
Los Angeles, California, United States
Contact
-
Michelle C Cardenas, MSN, NP
(310) 794-3070 mccardenas@mednet.ucla.edu
-
Ankush sachdeva
310-794-7700 ASachdeva@mednet.ucla.edu
Potential match only. Final eligibility is determined by the study team.