Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030290
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2002-02-14
Brief Title:
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
Sponsor:
Focus Surgery
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue
PURPOSE Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate
PURPOSE Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate
Detailed Description:
OBJECTIVES
Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue with resultant drop in PSA levels to below 05 ngmL and negative biopsy for cancer cells in patients with organ-confined prostate cancer
OUTLINE This is a multicenter study
A probe is inserted into the rectum High-intensity focused ultrasound HIFU energy using the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours Patients with residual cancer lesion by biopsy PSA greater than 05 ngmL or increasing PSA levels taken at least 2 months apart visible prostate tissue on ultrasound and no local or distant metastases after day 90 undergo retreatment with HIFU
Patients are followed at 2 14 30 90 and 180 days
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue with resultant drop in PSA levels to below 05 ngmL and negative biopsy for cancer cells in patients with organ-confined prostate cancer
OUTLINE This is a multicenter study
A probe is inserted into the rectum High-intensity focused ultrasound HIFU energy using the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours Patients with residual cancer lesion by biopsy PSA greater than 05 ngmL or increasing PSA levels taken at least 2 months apart visible prostate tissue on ultrasound and no local or distant metastases after day 90 undergo retreatment with HIFU
Patients are followed at 2 14 30 90 and 180 days
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1684 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069126 | REGISTRY | None | None |
| CWRU-050130 | None | None | None |
| IUMC-010233 | None | None | None |