NCT00561314

High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer

An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.

Detailed description

OBJECTIVES: Primary * To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate. Secondary * To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy. OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients are then evaluated over a 12-month period. Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response. Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.

Conditions

• Prostate Cancer
• Sexual Dysfunction
• Urinary Incontinence

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	biopsy
PROCEDURE	high-intensity focused ultrasound ablation
PROCEDURE	magnetic resonance imaging
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-02-01
• Completion: 2012-01-01
• First posted: 2007-11-20
• Last updated: 2013-08-26

Locations

2 sites across 1 country: United Kingdom