Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease
The study includes the recruitment of patients with advanced prostate cancer resistant to
chemical castration This is a multicenter prospective trial randomized phase III This study
design that includes a double randomizzzazione aims generally demonstrating non-inferiority
in terms of survival of the suspension dell'ormonoterapia versus the maintenance and / or
administration of intermittent versus continuous administration of chemotherapy in patients
with prostate cancer resistant to chemical castration I started to line chemotherapy with
Docetaxel.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
The primary aim of the study will be the demonstration of non inferiority in terms of overall survival of stopping androgen deprivation therapy (arm B) versus maintenance androgen deprivation therapy (arms A) and intermittent docetaxel therapy (arm AB1) versus continuous docetaxel therapy (arms AB2) up to ten cycles.
six years
Yes
Alfredo Berruti, PHD
Study Chair
Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy
Italy: The Italian Medicines Agency
EudraCT 2010-019004-24
NCT01224405
April 2010
April 2016
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