Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182052
Status:
COMPLETED
Last Update Posted:
2013-05-23
First Post:
2005-09-14
Brief Title:
Rosiglitazone Avandia vs Placebo for Androgen Dependent Prostate Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Rosiglitazone Avandia vs Placebo for Androgen Dependent Prostate Cancer A Randomized Double-Blind Placebo Controlled Phase III Study
Status:
COMPLETED
Status Verified Date:
2013-05
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 purpose of this study it to learn the effects good or bad that rosiglitazone has on patients and their prostate cancer This study is going to look at what effects rosiglitazone has on prostate specific antigen PSA levels
Detailed Description:
Patients will be randomly assigned to initial treatment with either rosiglitazone or placebo orally twice daily every day as long as there is no disease progression or serious side effects Patients will be asked to complete a drug log to keep track of the medication
Before treatment begins the following tests will be performed physical exam bone scan blood work including PSA level test and a urine sample
While on this study the following tests and procedures will be done once a month review of side effects and routine blood tests including PSA levels
While on this study the following tests and procedures will be done on months 2 and 4 review of side effects routine blood tests including PSA levels and urine tests
If the patients disease progressed the treatment code will be broken and if the patient was on placebo they will have the option to begin taking rosiglitazone
Before treatment begins the following tests will be performed physical exam bone scan blood work including PSA level test and a urine sample
While on this study the following tests and procedures will be done once a month review of side effects and routine blood tests including PSA levels
While on this study the following tests and procedures will be done on months 2 and 4 review of side effects routine blood tests including PSA levels and urine tests
If the patients disease progressed the treatment code will be broken and if the patient was on placebo they will have the option to begin taking rosiglitazone
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