A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

Inclusion Criteria:

• Clinical diagnosis of metastatic prostate cancer.
• Serum testosterone within institutional limits of normal.
• PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
• DEXA scan within 2 years prior to registration.
• ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
• LVEF within 42 days prior to registration and within institutional limits of normal.
• Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
• Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
• Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
• Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.

Phase III
Gary Goodman, M.D.
SWOG (Southwest Oncology Group)
Scot Lary

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.