High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
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.
Other: questionnaire administration
Procedure: high-intensity focused ultrasound ablation
Procedure: quality-of-life assessment
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate|
- Feasibility [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: No ]
- Side effect profile [ Designated as safety issue: Yes ]
- Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir [ Designated as safety issue: No ]
- Exclusion of cancer on MRI at 2-7 days and at 6 months [ Designated as safety issue: No ]
- Transrectal ultrasound biopsies at 6 months [ Designated as safety issue: No ]
- Need for secondary or adjuvant treatment for prostate cancer following therapy [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561262
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Study Chair:||Mark Emberton, MD, FRCS, MBBS||University College London Hospitals|