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Spots Global Cancer Trial Database for Trilostane for Androgen-Independent Prostate Cancer

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Trial Identification

Brief Title: Trilostane for Androgen-Independent Prostate Cancer

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

Study ID: NCT00181597

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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Massachusetts General Hospital, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Contact Details

Name: Medical Monitor

Affiliation: Genzyme, a Sanofi Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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