C21005:Study of Orteronel with prednisone for prostate cancer patients
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy
IRAS ID
62723
Contact name
Peter Hoskin
Sponsor organisation
Millennium Pharmaceuticals, Inc
Eudract number
2010-018662-23
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is a common cause of male cancer-related deaths in the UK, United States and Europe. It is initially treated by reducing testosterone, the male hormone involved in prostate cancer growth. If disease worsens despite testosterone reduction, therapies are available but response to these is only modest and short-lived. Once the cancer progresses, docetaxel in combination with prednisone is frequently used. Although this treatment improves survival, average survival is still less than 2 years and prostate cancer that has spread remains an incurable disease.Certain receptors remain active in patients that have had testosterone reduction suggesting that a further reduction in testosterone production is important. Orteronel is a new drug which blocks steps in the testosterone production pathway. Orteronel has been tested in 3 completed and 3 ongoing studies.The purpose of this study is to determine whether orteronel plus prednisone improves overall survival. Men with prostate cancer that has progressed following one or two prior chemotherapies, one of which must have included docetaxel, may be eligible to participate.Patients will be randomly assigned to receive orteronel or placebo in combination with prednisone. They will have a 66% chance of receiving orteronel and a 33% chance of receiving placebo. Patients will continue to take study drug until they start another treatment, experience unacceptable side effects or withdraw from study visits. Long-term follow up will continue until death or the sponsor stopping the study.Patients will attend study visits every 4 weeks until Cycle 7, then every 3 months. During these visits, procedures performed will include physical examination, vital signs, ECG, blood sample collection, questionnaire completion, MUGA, CT/MRI and bone scans.This study is sponsored by Millennium. Approximately 1083 patients will participate in this study worldwide with 39 patients from 9 hospitals in the UK.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
10/H0406/76
Date of REC Opinion
22 Nov 2010
REC opinion
Further Information Favourable Opinion