Trilostane for Androgen-Independent Prostate Cancer
This study has been completed.
Genzyme, a Sanofi Company
Information provided by:
First received: September 9, 2005
Last updated: December 2, 2013
Last verified: December 2013
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer|
Resource links provided by NLM:
Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone butyrate Trilostane Hydrocortisone valerate Hydrocortisone probutateU.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- activity of trilostane in men with androgen-independent prostate cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- serum levels of gonadal and adrenal steroids [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Intervention Details:Detailed Description:
Taken orally once a day for three days then twice daily thereafter.Drug: Hydrocortisone
Taken orally with trilostane.
- 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, and/or 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181597
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
Sponsors and Collaborators
Genzyme, a Sanofi Company
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|