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Brief Title: TAK-700 in Castration Resistant Prostate Cancer
Official Title: Phase II Randomized Comparative Trial of TAK-700 (Orteronel) Versus Bicalutamide in Metastatic Prostate Cancer Patients Failing 1st Line Treatment With LHRH Agonists or Surgical Castration.
Study ID: NCT01658527
Brief Summary: The objective of this randomized phase II open label trial is to determine the anti-tumor activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Onze Lieve Vrouw Ziekenhuis, Aals, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
AZ Groeninge Kortrijk - Campus Vercruysselaan, Kortrijck, , Belgium
CHU Dinant Godinne - UCL Namur, Yvoir, , Belgium
Name: Cora Sternberg
Affiliation: San Camillo Forlanini Hospitals, Rome, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Bertrand Tombal
Affiliation: Cliniques Universitaires de St Luc, Brussels, Belgium
Role: STUDY_CHAIR