High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00561262
- Lead Sponsor
- University College London Hospitals
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility 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
- Secondary Outcome Measures
Name Time Method Transrectal ultrasound biopsies at 6 months 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 Need for secondary or adjuvant treatment for prostate cancer following therapy
Trial Locations
- Locations (1)
University College of London Hospitals
🇬🇧London, England, United Kingdom