Trilostane for Androgen-Independent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00181597|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma||Drug: Trilostane Drug: Hydrocortisone||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
- Drug: Trilostane
Taken orally once a day for three days then twice daily thereafter.
- Drug: Hydrocortisone
Taken orally with trilostane.
- activity of trilostane in men with androgen-independent prostate cancer. [ Time Frame: 4 years ]
- serum levels of gonadal and adrenal steroids [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181597
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|