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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To analyze possible AR related mechanisms of abiraterone acetate resistance in serial CRPC metastasis biopsies.

Outcome Description:

To analyze possible AR related mechanisms of abiraterone acetate resistance in serial CRPC metastasis biopsies (including AR sequence-mutations/splice variants, AR regulated gene expression, tumor androgen levels and profiling enzymes involved in androgen synthesis and metabolism).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mary-Ellen Taplin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-448

NCT ID:

NCT01393730

Start Date:

September 2011

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • prostate
  • metastatic
  • castrate resistant
  • Prostatic Neoplasms

Name

Location

University of Washington Medical CenterSeattle, Washington  98195-6043
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Seattle Cancer Care AllianceSeattle, Washington  98109