Trilostane for Androgen-Independent Prostate Cancer

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Androgens; Cortisol succinate; Dihydrotestosterone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Trilostane

Criteria

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