Prostate Cancer Clinical Trial
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant 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
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There are 42 Locations for this study
Anchorage Alaska, 99508, United States
Fort Smith Arkansas, 72903, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90025, United States
Riverside California, 92501, United States
San Diego California, 92120, United States
Fort Myers Florida, 33916, United States
Port Saint Lucie Florida, 34952, United States
Indianapolis Indiana, 46219, United States
Jeffersonville Indiana, 47130, United States
New Orleans Louisiana, 70112, United States
Westminster Maryland, 21157, United States
Detroit Michigan, 48201, United States
Jefferson City Missouri, 65109, United States
Las Vegas Nevada, 89169, United States
Hackensack New Jersey, 07601, United States
Albany New York, 12208, United States
East Syracuse New York, 13057, United States
Rochester New York, 14623, United States
Raleigh North Carolina, 27607, United States
Cincinnati Ohio, 45230, United States
Tualatin Oregon, 97062, United States
Lancaster Pennsylvania, 17604, United States
Pittsburgh Pennsylvania, 15212, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79106, United States
Bedford Texas, 76022, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Odessa Texas, 79761, United States
Tyler Texas, 75702, United States
Webster Texas, 77598, United States
Salt Lake City Utah, , United States
Newport News Virginia, 23606, United States
Kennewick Washington, 99336, United States
Redcliffe Queensland, , Australia
Woodville South South Australia, 5011, Australia
Hobart Tasmania, , Australia
Malvere Victoria, , Australia
Wodonga Victoria, , Australia
Brussels , , Belgium
Kortijk , , Belgium
Liege , , Belgium
Namur , , Belgium
Edmonton Alberta, , Canada
Kelowna British Columbia, V1Y2H, Canada
Moncton New Brunswick, , Canada
Brampton Ontario, L6T4S, Canada
Newmarket Ontario, , Canada
Greenfield Park Quebec, J4V2H, Canada
Montreal Quebec, , Canada
Pointe-Claire Quebec, H9R4S, Canada
Hradec Dralove , , Czechia
Kromertz , , Czechia
Modrice , , Czechia
Praha , , Czechia
Zlin , , Czechia
Tallinn , , Estonia
Oulu , , Finland
Tampere , , Finland
La Roche-sur-Yon , , France
Le Mans , , France
Lyon Cedex , , France
Lyon , , France
Marseille , , France
Paris , , France
Villejuif cedex , 94805, France
Patras , , Greece
Miskolc , , Hungary
Osztaly , , Hungary
Novara , , Italy
Rome , , Italy
Eindhoven , , Netherlands
Bielsko-Biala , , Poland
Goczalkowice-Zdroj , , Poland
Wroclaw , , Poland
Sevilla , , Spain
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