HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Sonablate HIFU device


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIFU Study Participants<br>Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the HIFU procedure as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study. The HIFU device currently used in this standard-of-care procedure at UCLA is the Sonablate 450 HIFU System. | Device: Sonablate HIFU device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological Response | The following definitions will be used for evaluation of oncological response: Complete response: Ablation of prostate tissue in targeted biopsy cores at 6 months and 18 months post-procedure biopsy and resolution of initial mp-MRI abnormality. Incomplete radiographic response: Residual mp-MRI abnormality at 6 months compared to baseline Local failure: Failure to ablate prostate tissue | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Quality-of-Life Symptoms (EPIC-CP) | The EPIC-CP questionnaire will be used to evaluate urinary, bowel and sexual health quality-of-life symptoms for participants pre- and post-HIFU. | 6 months | 
| Evaluation of Quality-of-Life Symptoms (EPIC-CP) | The EPIC-CP questionnaire will be used to evaluate urinary, bowel and sexual health quality-of-life symptoms for participants pre- and post-HIFU. | 18 months | 
| Decisional Regret Scale | This questionnaire data will be collected to assess for subjects' decision-making satisfaction. | 18 months |