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PR17 Details
Status: Closed 
Activation Date: 2015FEB02
Closing Date: 2017MAR24
Phase: III 

Description: Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET 

Eligibility: Men starting first line androgen deprivation therapy for metastatic adenocarcinoma of the prostate. Key eligibility criteria include metastatic prostate cancer, adequate organ function and ECOG performance status 0-2. 

Objective: Primary endpoint: Overall survival 

Participation: Open to member centres 

Lay Description: The purpose of this study is to determine the effectivetness of enzalutamide (a more potent and effective androgen receptor blocker), compared to conventional non-steroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide), when combined with a luteinising hormone releasing hormone analogue (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for metastatic prostate cancer. You may be eligible for this trial if you aged 18 years or above and have prostate cancer that has spread beyond your prostate but are otherwise in relatively good health. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants randomised to Group 1 will receive Enzalutamide daily, and patients randomised to Group 2 will receive Conventional NSAA. Both treatments are taken by mouth and will continue until your disease worsens or if you have side effects. Both groups will also be treated with a LHRHA or surgical castration.  

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