Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.

Key facts

Study ID

NCT01393730

Run by

Mary-Ellen Taplin, MD

People needed

40

Starts

2011-09-01

Expected to finish

2017-03-15

Last updated by the study team

2018-03-15

Who can join

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

You may qualify if…

• Diagnosis of adenocarcinoma of the prostate
• Castrate resistant disease
• Metastatic disease
• Normal organ and marrow function
• Subjects with partners of childbearing potential must be willing to use adequate methods of birth control

You may not qualify if…

• Uncontrolled intercurrent illness
• Uncontrolled hypertension
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease
• History of a different malignancy unless disease-free for at least 5 years
• Known brain metastasis
• History of gastrointestinal disorders
• Prior therapy with abiraterone acetate
• HIV-positive individuals on antiretroviral therapy
• Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
• Atrial fibrillation or other cardiac arrhythmia requiring therapy
• Thromboembolism in the last 6 months

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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