A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
- Patients will take trilostane orally once a day for three days, then twice a day
- Patients will complete a daily drug log recording the date, time and number of capsules
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
activity of trilostane in men with androgen-independent prostate cancer.
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|