Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005075|
Recruitment Status : Terminated (Withdrawn because Ablatherm devices were not available anymore at trial centers)
First Posted : February 25, 2004
Last Update Posted : November 6, 2013
RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer.
PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating patients who have stage I or stage II prostate cancer that has recurred following radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: high-intensity focused ultrasound ablation||Phase 3|
OBJECTIVES: I. Determine the effectiveness of the Ablatherm high-intensity focused ultrasound device in providing control of disease for at least 12 months after treatment in patients with stage I or II prostate cancer recurring after external beam radiotherapy. II. Determine the safety of this treatment device in these patients.
OUTLINE: This is an open-label, multicenter study. A probe is inserted into the rectum. Ultrasound energy is then delivered through probe to prostate tissue over 2-3 hours. Quality of life is assessed at study initiation; at 14 days and 3, 6, and 12 months; and then annually thereafter. Patients are followed at 14 days; at 3, 6, 9, and 12 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Evaluation of the Ablatherm High Intensity Focused Ultrasound Device After Failed Radiation Therapy for Localized Prostate Cancer|
|Study Start Date :||July 1999|
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): NCT00005075
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Study Chair:||Suzanne Courtney, MD||EDAP Technomed|