The primary purpose of the study is to determine the percentage of patients who achieve a prostate-specific antigen (PSA) ≤0.2ng/mL following three months of TAK-700.

This study is an open-label, multicenter, phase II study of TAK-700 in patients with nonmetastatic CRPC and rising PSA.

Study Requirements

It is expected that approximately 42 patients will be enrolled in this study. Once enrolled into the study, patients will be administered oral TAK-700.

Each 28-day treatment cycle is composed of continuous BID TAK-700 treatment. Patients may receive TAK-700 until they experience the first of (a) PSA progression or (b) metastasis.

Inclusion Criteria

Each patient must meet all of the following inclusion criteria:

• Male patients 18 years or older
• Eastern Cooperative Oncology Group performance status 0-1
• Practice effective barrier contraception to one month after the last dose of study drug, or abstain from heterosexual intercourse
• Voluntary written consent
• Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA despite castrate concentrations of testosterone
• Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to eight months or baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than eight months
• Has undergone orchiectomy or will continue receiving GnRH analogue therapy
• Meet screening laboratory values as specified in protocol

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

• Known hypersensitivity to TAK-700 or related compounds
• Received any of the following within 30 days prior to the first dose of TAK-700: prior therapy with aminoglutethimide or ketoconazole; any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; or chronic therapy with corticosteroids
• Received antiandrogen therapy within four weeks for flutamide and six weeks for all others prior to first dose of study drug
• Received prior chemotherapy for prostate cancer
• Current spinal cord compression, bilateral hydronephrosis, or neck outlet obstruction
• Symptoms that investigator deems related to prostate cancer
• Diagnosis or treatment of another malignancy within two years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
• History of adrenal insufficiency
• Uncontrolled cardiovascular condition
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• Unwilling or unable to comply with protocol
• Major surgery or serious infection within 14 days of first dose of TAK-700
• Life-threatening illness unrelated to cancer
• Uncontrolled nausea, vomiting, or diarrhea
• Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700

For more information, contact Karla Morris at 919-668-8375.