High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00987675|
Recruitment Status : Unknown
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 1, 2009
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: pharmacological study Other: questionnaire administration Procedure: assessment of therapy complications Procedure: high-intensity focused ultrasound ablation Procedure: quality-of-life assessment||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Official Title:||An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2011|
- 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
- Success of treatment as demonstrated by the absence of cancer at 6 months
- PSA kinetics after completion of treatment
- Proportion of patients requiring androgen blockade at 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987675
|University College Hospital||Recruiting|
|London, England, United Kingdom, WIT 3AA|
|Contact: Hashim Uddinn Ahmed, MD 44-20-7380-9194|
|OverallOfficial:||Hashim Uddinn Ahmed, MD||University College London Hospitals|