A Phase 1b Safety Study of Abiraterone Acetate (JNJ 212082) and Docetaxel in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (COU-AA-206)

Study Status

Open to Enrollment

Study Description

This research study is an early step in the evaluation of two FDA approved medications in combination for the treatment of metastatic prostate cancer. The purpose of the study is to determine a safe dose combination of two highly active drugs, abiraterone acetate (Zytiga) and docetaxel (Taxotere) in patients with metastatic castration-resistant (hormone insensitive) prostate cancer (mCRPC).

Abiraterone acetate is a drug that blocks any remaining male hormones in the body that may be helping prostate cancer to grow. The drug was recently approved by the FDA for treatment mCRPC after patients who have already received docetaxel, but it has not yet been approved to be given in combination with docetaxel or in men who have not yet received docetaxel.

Patients will take the study medication daily. Patients will also receive docetaxel via IV infusion every 3 weeks in the clinic. Dexamethasone tablets will be given before the start of each docetaxel infusion. All patients will also take prednisone tablets throughout the study. Most patients will need to continue taking and LHRH analog they were receiving prior to the start of the study.

Patients will remain on the study drug until disease worsens, significant side effects occur or if they can no longer tolerate treatment.

Disease Status and/or Stage

Metastatic Castration-Resistant Prostate Cancer


Cougar Biotechnology

Key Eligibility

  • Men age 18 and older
  • Diagnosed with metastatic prostate cancer
  • Cancer has progressed despite either orchiectomy or hormonal therapy
  • Has not taken abiraterone or received docetaxel chemotherapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

David Nanus, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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