HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03620786
• Other study ID #: 16-000904
• Status: Recruiting
• Start date: September 26, 2018
• Est. completion date: January 31, 2028

Study information

• Verified date: January 2024
• Source: University of California, Los Angeles
• Contact: Merdie Delfin, MSN, NP
• Phone: (310) 794-3070
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2027
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Decisional Regret Scale	This questionnaire data will be collected to assess for subjects' decision-making satisfaction.	18 months