High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00561262|
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : August 26, 2013
RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue.
PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: questionnaire administration Procedure: high-intensity focused ultrasound ablation Procedure: quality-of-life assessment||Phase 2|
- To determine patient acceptability, feasibility, and side-effect profile by evaluating records of adverse events.
- To determine patient acceptability, feasibility, and side-effect profile by evaluating urinary symptoms and erectile function before study stage 1 (verification), before study stage 2 (treatment), and at each follow-up visit.
- To determine the effectiveness of therapy by post-treatment transrectal ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure.
- To determine the effectiveness of therapy by post-treatment MRI to evaluate area of necrosis and presence of any residual tissue.
- To determine the effectiveness of therapy by measurement of prostate-specific antigen (PSA) at each follow-up visit and measurement of time to PSA nadir.
- To determine the effectiveness of therapy by recording the need for secondary or adjuvant treatment following therapy.
OUTLINE: Patients undergo hemiablation using high-intensity focused ultrasound to the side of the prostate with cancer and up to 5 mm over into the contralateral side to ensure adequacy.
Patients complete questionnaires periodically during study to assess urinary symptoms and erectile dysfunction. These include the International Index of Erectile Function-15 [IIEF-15]; the International Prostate Symptom Score [IPSS] and IPSS-QoL; the Functional Assessment of Cancer Therapy - Prostate (FACT-P); and the Continence Questionnaire.
After completion of study treatment, patients are followed at 2-7 days, 7-14 days, and at 1, 3, 6, 9, and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Official Title:||An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate|
|Study Start Date :||May 2006|
|Primary Completion Date :||October 2009|
|Study Completion Date :||April 2011|
- Adverse events
- Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function
- Side effect profile
- Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir
- Exclusion of cancer on MRI at 2-7 days and at 6 months
- Transrectal ultrasound biopsies at 6 months
- Need for secondary or adjuvant treatment for prostate cancer following therapy
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): NCT00561262
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Study Chair:||Mark Emberton, MD, FRCS, MBBS||University College London Hospitals|