Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181597
Status:
COMPLETED
Last Update Posted:
2013-12-03
First Post:
2005-09-09
Brief Title:
Trilostane for Androgen-Independent Prostate Cancer
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-12
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:
The main purpose of this study is to test the safety of trilostane by looking at what effects good and bad it has on patients with androgen-independent prostate cancer
Detailed Description:
Patients will take trilostane orally once a day for three days then twice a day thereafter
Patients will complete a daily drug log recording the date time and number of capsules taken
Trilostane may moderately decrease the production of steroids by the adrenal glands In order to prevent any symptoms related to decreased steroid production patients will also take hydrocortisone at the same time as the trilostane
While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels Blood pressure and pulse rate will also be taken every 4 weeks
Depending upon disease status radiological testing CT scan x-rays andor bone scan may be repeated every 12 weeks
Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects
Patients will complete a daily drug log recording the date time and number of capsules taken
Trilostane may moderately decrease the production of steroids by the adrenal glands In order to prevent any symptoms related to decreased steroid production patients will also take hydrocortisone at the same time as the trilostane
While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels Blood pressure and pulse rate will also be taken every 4 weeks
Depending upon disease status radiological testing CT scan x-rays andor bone scan may be repeated every 12 weeks
Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects
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