NCT00987675

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

An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University College London Hospitals · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: High-intensity focused ultrasound ablation uses high-energy sound waves to kill tumor cells. PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound ablation and to see how well it works in treating patients with progressive prostate cancer.

Detailed description

OBJECTIVES: Primary * To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer. Secondary * To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy. * To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients. * To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up. OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment. Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months. After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	pharmacological study
OTHER	questionnaire administration
PROCEDURE	assessment of therapy complications
PROCEDURE	high-intensity focused ultrasound ablation
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• First posted: 2009-10-01
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom