Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030277
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2002-02-14
Brief Title:
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Sponsor:
Focus Surgery
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the 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 This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer
PURPOSE This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer
Detailed Description:
OBJECTIVES
Determine the ability of Sonablate to focus ultrasound 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 locally recurrent prostate cancer
OUTLINE Patients are stratified according to prior treatment failure brachytherapy vs post-external beam radiotherapy
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 hours Patients with residual cancer lesion by biopsy PSA greater than 05 ngmL or increasing PSA levels taken 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 10 per stratum will be accrued for this study
Determine the ability of Sonablate to focus ultrasound 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 locally recurrent prostate cancer
OUTLINE Patients are stratified according to prior treatment failure brachytherapy vs post-external beam radiotherapy
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 hours Patients with residual cancer lesion by biopsy PSA greater than 05 ngmL or increasing PSA levels taken 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 10 per stratum 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-V01-1683 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069125 | REGISTRY | None | None |
| IUMC-010235 | None | None | None |