Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2017-03-15
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mary-Ellen Taplin, MD
• Treatments: Abiraterone Acetate; Dutasteride; Prednisone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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