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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Low-risk disease, as defined by the following criteria:
Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
No metastatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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