NCT00181597

Trilostane for Androgen-Independent Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Trilostane	Taken orally once a day for three days then twice daily thereafter.
DRUG	Hydrocortisone	Taken orally with trilostane.

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-09-16
• Last updated: 2013-12-03

Locations

2 sites across 1 country: United States