study comparing orteronel plus prednisone in participants with metastatic castration-resistant prostate cancer.

Conditions: Prostate Cancer

Summary: this is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mcrpc) that has progressed following docetaxel-based therapy


Eligibility criteria:
inclusion criteria: each participant must meet all of the following inclusion criteria: * voluntary written consent * male 18 years or older * histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * radiograph-documented metastatic disease * progressive disease * prior surgical castration or concurrent use of an agent for medical castration * progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. must have received greater than or equal to (\>=) 360 milligram per square meter (mg/m\^2) of docetaxel within a 6-month period. participants who were clearly intolerant to docetaxel or develop progressive disease before receiving \>= 360 mg/m\^2 are also eligible if they have received at least 225 mg/m\^2 of docetaxel within a 6-month period and meet the other study entry criteria. * eastern cooperative oncology group (ecog) performance status 0 to 2 * even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or abstain from heterosexual intercourse * screening laboratory values as specified in protocol * stable medical condition * life expectancy of 6 months or more * participants who have had up to 2 prior chemotherapy treatments are eligible to participate exclusion criteria: participants meeting any of the following exclusion criteria are not to be enrolled in the study: * known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (gnrh) analogue * received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone * any other therapies for prostate cancer, except for gnrh analogue therapy, must be discontinued 2 weeks before the first dose of study drug * radioisotope therapy or external beam radiation therapy within 4 weeks of first dose of study drug * documented central nervous system metastases * treatment with any investigational compound within 30 days prior to first dose of study drug (participants who are in long-term follow-up following active treatment in other trials are eligible) * diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected * uncontrolled cardiovascular condition as specified in study protocol * known history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c * unwilling or unable to comply with protocol * known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel * uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy * prostate cancer confined to just the prostrate bed or immediate adjacent tissue

Keywords: drug therapy