High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
Recruitment status was: Recruiting
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.
Other: pharmacological study
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: high-intensity focused ultrasound ablation
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer|
- Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months [ Designated as safety issue: No ]
- Success of treatment as demonstrated by the absence of cancer at 6 months [ Designated as safety issue: No ]
- PSA kinetics after completion of treatment [ Designated as safety issue: No ]
- Proportion of patients requiring androgen blockade at 12 months [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987675
|University College Hospital|
|London, England, United Kingdom, WIT 3AA|
|OverallOfficial:||Hashim Uddinn Ahmed, MD||University College London Hospitals|