Trilostane for Androgen-Independent Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00181597

Run by

Genzyme, a Sanofi Company

People needed

24

Starts

2004-03-01

Expected to finish

2006-01-01

Last updated by the study team

2013-12-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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