Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005075
Status:
TERMINATED
Last Update Posted:
2013-11-06
First Post:
2000-04-06
Brief Title:
Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
Sponsor:
EDAP Technomed
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of the Ablatherm High Intensity Focused Ultrasound Device After Failed Radiation Therapy for Localized Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn because Ablatherm devices were not available anymore at trial centers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GUMC-99034 | None | None | None |
| EDAP-G980308 | None | None | None |