Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
Trilostane, Androgen-independent prostate cancer
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, 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.
Interventions
DRUGTrilostane
Taken orally once a day for three days then twice daily thereafter.
DRUGHydrocortisone
Taken orally with trilostane.
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed prostate adenocarcinoma * Disease progression despite androgen depravation therapy and antiandrogen withdrawal * Progressive measurable disease or bone scan progression or PSA progression * Serum total testosterone \< 50ng/ml * Creatinine \< 2.0 mg/dl * ALT \< 2 x ULN * CALGB performance status of 0,1, or 2
Exclusion criteria
* Radiation therapy within 4 weeks * Antiandrogen within 8 weeks * Other secondary hormonal therapy or investigational agents within 4 weeks * Prior chemotherapy for androgen-independent prostate cancer * History of adrenal insufficiency * Known brain metastases * Severe liver or renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| activity of trilostane in men with androgen-independent prostate cancer. | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| serum levels of gonadal and adrenal steroids | 4 years |
Countries
United States
Outcome results
None listed