High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00988130|
Recruitment Status : Unknown
Verified May 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Sexual Dysfunction||Other: laboratory biomarker analysis 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Masking:||None (Open Label)|
|Official Title:||HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer|
|Study Start Date :||July 2009|
- Total proportion of men with erectile dysfunction and/or incontinence
- Quality of life
- Success of index lesion ablation with HIFU at 6 months
- Prostate-specific antigen kinetics
- Proportion of men 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): NCT00988130
|University College Hospital - London||Recruiting|
|London, England, United Kingdom, WIT 3AA|
|Contact: Mark Emberton, MD, FRCS, MBBS 44-20-7380-9194|
|Principal Investigator:||Mark Emberton, MD, FRCS, MBBS||University College London Hospitals|