S1216: Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

Study Status

Open to Enrollment

Study Description

This clinical trial is for men with metastatic prostate cancer who are either beginning hormone therapy for the first time, or have been on hormone therapy for less than 30 days.

The purpose of the study is to determine the effectiveness of adding the experimental drug TAK-700 (also called orteronel, a CYP17 inhibitor) to standard hormone therapy.

TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help the prostate cancer grow. TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced. It is expected that, by lowering the amount of male hormones in the body, TAK-700 will control the growth of prostate cancer.

Study participants will be randomly assigned to one of two treatment arms:

  • Arm 1, Standard Hormone Therapy + TAK-700
    • Leuprolide acetate (Lupron) or goserelin acetate (Zoladex) injection once every 3 months
    • TAK-700 tablet by mouth twice a day
  • Arm 2, Standard Hormone Therapy
    • Leuprolide acetate (Lupron) or goserelin acetate (Zoladex) injection once every 3 months
    • Bicalutamide (Casodex) tablet by mouth once a day

Study participants will receive hormone therapy combined with either TAK-700 (Arm 1) or bicalutamide (Arm 2) for as long as they are responding to treatment and not experiencing unacceptable side effects.

Disease Status and/or Stage

Metastatic Prostate Cancer

Sponsor

SWOG

Key Eligibility

  • Metastatic prostate cancer
  • Have either not yet started hormone therapy or have been on hormone therapy for less than 30 days
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Scott Tagawa, MD

Contact

Protocol ID

S1216


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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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