HIFU for Focal Ablation of Prostate Tissue: An Observational Study
Recruiting · NCT03620786 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
Sonablate HIFU device
What this trial is about
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.
Who can take part
Age range
40 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.)
Where it is running
1 location listed across 1 US state.
- University of California, Los Angeles - Los Angeles, California, United States