HIFU for Focal Ablation of Prostate Tissue: An Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonablate HIFU device.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 40 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
Overview
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.
Detailed description
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.
Interventions
- Device Sonablate HIFU device
In this study, we will be using the Sonablate 450 HIFU System. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015. HIFU is an example of focal therapy, where the intervention involves targeting diseased areas of prostate tissue, while preserving healthy prostate tissue and minimizing damage to surrounding structures.
Primary outcome measures
- Oncological Response [Time frame: 6 months]
Secondary outcome measures (3)
- Evaluation of Quality-of-Life Symptoms (EPIC-CP) [Time frame: 6 months]
- Evaluation of Quality-of-Life Symptoms (EPIC-CP) [Time frame: 18 months]
- Decisional Regret Scale [Time frame: 18 months]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, Los Angeles — Los Angeles
Identifiers
NCT: NCT03620786 · 16-000904