Trilostane for Androgen-Independent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181597
• Other study ID #: 04-037
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 2, 2013
• Start date: March 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Trilostane
Taken orally once a day for three days then twice daily thereafter.
• Hydrocortisone
Taken orally with trilostane.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activity of trilostane in men with androgen-independent prostate cancer.		4 years	No
Secondary	serum levels of gonadal and adrenal steroids		4 years	No