Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Abiraterone acetate (Drug); Dutasteride (Drug); Prednisone (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Mary-Ellen Taplin, MD Official(s) and/or principal investigator(s):
Mary-Ellen Taplin, M.D., Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To analyze possible AR related mechanisms of abiraterone acetate resistance in serial CRPC metastasis biopsies.
Secondary outcome: Assessment of serum levels of testosterone, dihydrotestosterone and androgen precursors at baseline and at progression.Assessment of PSA response Assessment of PSA response duration on Abiraterone acetate-prednisone/Dutasteride To assess response of measurable disease if present To assess time to progression of bone lesions or measurable disease (RECIST) Assessment of toxicity of Abiraterone acetate and Dutasteride To correlate presence of AR amplification To measure serum androgens and CTCs Evaluation of methods for using CTCs for RNA based expression profiling of AR and AR regulated genes as an exploratory endpoint.
Detailed description:
Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2
cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once
daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood
tests.
Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT
scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other
specialized blood test.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States
Seattle Cancer Care Alliance, Seattle, Washington 98109, United States
University of Washington Medical Center, Seattle, Washington 98195, United States
Additional Information
Starting date: September 2011
Last updated: June 2, 2015
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