Trilostane for Androgen-Independent Prostate Cancer

• Sponsor: Genzyme, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00181597
• Collaborator: (none)
• Enrollment: 24
• Locations: 2
• Duration (Months): 22
• Patients Per Site: 12
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostate Adenocarcinoma	Drug: Trilostane; Drug: Hydrocortisone	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. activity of trilostane in men with androgen-independent prostate cancer. [4 years]

Secondary Outcome Measures

1. serum levels of gonadal and adrenal steroids [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Genzyme, a Sanofi Company

Investigators

• Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00181597
• Other Study ID Numbers: 04-037
• First Posted: Sep 16, 2005
• Last Update Posted: Dec 3, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by , ,: Trilostane; Androgen-independent prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Hydrocortisone; Trilostane

Study Results

No Results Posted as of Dec 3, 2013