Clinical trial · Observational
HIFU for Focal Ablation of Prostate Tissue: An Observational Study
High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
NCT03620786CI-TRIAL-00108464recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonablate HIFU device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HIFU Study Participants
- description
- 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.
- interventionNames
- Device: Sonablate HIFU device
Primary outcomes (1)
- measure
- Oncological Response
- timeFrame
- 6 months
- description
- The following definitions will be used for evaluation of oncological response: 1. 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. 2. Incomplete radiographic response: Residual mp-MRI abnormality at 6 months compared to baseline 3. Local failure: Failure to ablate prostate tissue
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 40 years to 85 years 2. 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) 3. PSA ≤ 20 4. Prostate volume of ≤ 70 cc 5. Ability to complete informed consent form Exclusion Criteria: 1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy) 2. Medical contraindication to follow-up mpMRI or prostate biopsy 3. Unable to tolerate general or regional anesthesia 4. 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.)
References
Publications (0)
Data not yet available
No reference posted for this study.