HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University College London Hospitals
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Total proportion of men with erectile dysfunction and/or incontinence
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: High-intensity focused ultrasound focal 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 focal ablation and to see how well it works in treating patients with progressive prostate cancer.
Detailed Description
OBJECTIVES: Primary * To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer. * To evaluate the quality of life of patients treated with this regimen. Secondary * To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy. * To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen. * To evaluate the proportion of men who require androgen blockade at 12 months of follow-up. OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease. Blood samples and prostate biopsies are collected periodically for further analysis. Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Total proportion of men with erectile dysfunction and/or incontinence
Quality of life
Secondary Outcomes
- Prostate-specific antigen kinetics
- Proportion of men requiring androgen blockade at 12 months
- Success of index lesion ablation with HIFU at 6 months