High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
Recruitment status was: Recruiting
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.
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: high-intensity focused ultrasound ablation
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer|
- Total proportion of men with erectile dysfunction and/or incontinence [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Success of index lesion ablation with HIFU at 6 months [ Designated as safety issue: No ]
- Prostate-specific antigen kinetics [ Designated as safety issue: No ]
- Proportion of men requiring androgen blockade at 12 months [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988130
|University College Hospital - London|
|London, England, United Kingdom, WIT 3AA|
|Principal Investigator:||Mark Emberton, MD, FRCS, MBBS||University College London Hospitals|