Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT01193257
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01193257
Study Brief:
Protocol Section:
NCT01193257