Ignite Creation Date:
2024-05-05 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00772317
Status:
UNKNOWN
Last Update Posted:
2019-04-10
First Post:
2008-10-14
Brief Title:
A Multicenter Clinical Study of the Sonablate450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU STAR Trial
Sponsor:
SonaCare Medical
Organization:
SonaCare Medical
Study Overview
Official Title:
A Multicenter Clinical Study of the Sonablate 450 Sonablate for the TreAtment of Locally Recurrent Prostate Cancer With HIFU STAR Trial
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
STAR
Brief Summary:
For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy EBRT
Detailed Description:
The proposed study is a non-randomized prospective single arm study The safety and effectiveness of the Sonablate treatment in subjects with locally recurrent prostate cancer will be evaluated with regard to freedom from biochemical failure and disease recurrence following HIFU treatment
Men with histologically confirmed locally recurrent organ-confined non-metastatic prostatic adenocarcinoma two or more years following EBRT PSA 05 ngmL and 10 ngmL 40 to 85 years of age and with initial staging of T1c-T2 prior to radiation who meet the criteria for salvage treatment will be enrolled
This pivotal study will cover pre-treatment through the 12-month post-treatment follow-up visit 8 visits
A 5 year extended follow-up study will be conducted annually for the 2nd-5th years post treatment 4 additional visits
Men with histologically confirmed locally recurrent organ-confined non-metastatic prostatic adenocarcinoma two or more years following EBRT PSA 05 ngmL and 10 ngmL 40 to 85 years of age and with initial staging of T1c-T2 prior to radiation who meet the criteria for salvage treatment will be enrolled
This pivotal study will cover pre-treatment through the 12-month post-treatment follow-up visit 8 visits
A 5 year extended follow-up study will be conducted annually for the 2nd-5th years post treatment 4 additional visits
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