Cancer

Title
Effects of Adding the New Investigational Drug TAK-700 to Standard Hormone Therapy as Compared with Standard Hormone Therapy Alone in Treatment of Prostate Cancer
Trial Number
205119032013
Number of Participants
1,636
Principal Investigator

Ellen R. Gaynor

M.D.
Hematology/Oncology
Professor
Eligibility

Patients who are at least18 years of age with the following criteria may be eligible:
• Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. All patients must have distant metastatic (brain metastases are not eligible).
• PSA = 2 ng/mL obtained within 90 days prior to initiation of androgen deprivation therapy for early induction or prior to registration for late induction
• Participants may not have Grade III/IV cardiac disease or uncontrolled hypertension
• Participants must have adequate hepatic, renal and hematologic function
• Participants must have a Zubrod performance status of 0 - 2

Purpose

The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy, which is used to treat prostate cancer as compared with the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.

Enrollment

(708) 327-3101

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