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.
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.
Each patient must meet all of the following inclusion criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
For more information, contact Karla Morris at 919-668-8375.