Trilostane for Androgen-Independent Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer

Conditions
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Prostate Cancer, Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: Trilostane
* Drug: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trilostane|Taken orally once a day for three days then twice daily thereafter.|
|Drug: Hydrocortisone|Taken orally with trilostane.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activity of trilostane in men with androgen-independent prostate cancer. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of gonadal and adrenal steroids |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trilostane, Androgen-independent prostate cancer