Prostate Cancer Clinical Trial
Official title:
An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
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.
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.
;
Primary Purpose: Treatment
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