orteronel in treating patients with metastatic hormone-resistant prostate cancer

Conditions: Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Summary: this phase ii trial studies how well orteronel works in treating patients with metastatic hormone-resistant prostate cancer. orteronel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

primary objectives: i. to assess the relationship between circulating tumor cell (ctc)-based androgen receptor (ar) expression level and \>=-50% prostate-specific antigen (psa) decline following 12 weeks of therapy with tak-700 (orteronel). secondary objectives: i. to assess changes in psa and ctc levels and time to psa progression (best response, decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based treatment. ii. to assess measurable disease response and time to radiographic disease progression for castration-resistant prostate cancer (crpc) with or without prior docetaxel-based treatment. iii. to explore relationships between endocrine and clinical responses. iv. to confirm the safety of tak-700 administered without prednisone in patients with metastatic crpc. outline: patients receive orteronel orally (po) twice daily (bid) on days 1-28. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * patients, even if surgically sterilized (i.e., status post vasectomy), who agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or * agree to completely abstain from intercourse * serum alanine aminotransferase (alt) and aspartate aminotransferase (ast) must be =\< 2.5 x the upper limit of normal (uln) * total bilirubin =\< 1.5 x uln * estimated creatinine clearance using the cockcroft-gault formula must be \> 40 ml/minute * absolute neutrophil count (anc) \>= 1500 cells/microliter * platelet count \>= 100,000 cells/microliter * testosterone \< 50 ng/dl * screening calculated ejection fraction of \>= 50% by multiple gated acquisition (muga) scan or echocardiogram; metastatic progression on primary androgen-deprivation therapy (medical or surgical castration) * progression requiring a change in oncologic therapy defined by any of the following: * radiographic progression: appearance or increase in measurable lesions on cross-sectional imaging or appearance of one or more new lesions on bone scan \* rising psa (\>= 2 ng/ml) which has risen on two occasions \>= 1 week apart * clinical progression evidenced by increased pain or other cancer-related symptoms * patients should have recovered from prior oncologic therapies to a common terminology criteria (ctc) grade =\ = 2 weeks from prior therapy; otherwise, the following time periods between prior anti-cancer therapies and study treatment day 1 will apply: * \>= 3 weeks for prior cytotoxic therapies * \>= 4 weeks for flutamide or nilutamide * \>= 6 weeks for bicalutamide * \>= 6 weeks since bone targeted radiopharmaceutical (e.g. samarium-153, radium-223) * gonadotropin-releasing hormone (gnrh) agonists (leuprolide acetate, goserelin, etc.) or antagonists (degarelix, etc.) should be continued in patients without surgically-induced castrate androgen levels * for chemotherapy naïve castration-resistant prostate cancer who are moderately symptomatic or who have hepatic metastasis: subjects must not be a candidate for docetaxel-based chemotherapy. exclusion criteria: * history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade \> 2 (nci ctcae, version 4), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within 6 months prior to first dose of study drug; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed * new york heart association class iii or iv heart failure * electrocardiogram (ecg) abnormalities of: * q-wave infarction, unless identified 6 or more months prior to screening * corrected qt (qtc) interval \> 460 msec * patient has received other investigational drugs within 28 days before enrollment * diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy * known hypersensitivity to compounds related to tak-700 or to tak-700 excipients * uncontrolled hypertension despite appropriate medical therapy (blood pressure \[bp\] of greater than 160 mmhg systolic and 90 mmhg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); note: patients may be rescreened after adjustment of antihypertensive medications * known active chronic hepatitis b or c, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study * likely inability to comply with the protocol or cooperate fully with the investigator and site personnel * known gastrointestinal (gi) disease or gi procedure that could interfere with the gi absorption or tolerance of tak-700, including difficulty swallowing tablets * prior treatment with \>= 3 lines of cytotoxic chemotherapy for metastatic prostate cancer * prior treatment with tak-700