Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 28 September 2016

Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone, abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in hormone naïve locally advanced...

purpose

Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone, abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in hormone naïve locally advanced or metastatic prostate cancer which ADT was indicated.


Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels
 

Arms Assigned Interventions
Active Comparator: Abiraterone acetate + Prednisone + ADT (Goserelin)
  • Abiraterone administered at a single 1000 mg daily oral dose (4 x 250-mg tablets)
  • Prednisone administered at a 5 mg twice daily oral dose
  • Goserelin administered as subcutaneous injections of 10.8mg every 3 months
Drug: Apalutamide
APALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.
Drug: Abiraterone
Abiraterone acetate 1,000 mg (four 250 mg tablets) should be taken orally once daily, in combination with oral dose prednisone 5mg twice daily continuously. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days
Drug: ADT
Dosing of goserelin (dose and frequency of administration) will be consistent with the prescribing information and should only be adjusted if clinically indicated to achieve and maintain subcastrate concentrations of testosterone (50 ng/dL or 1.7 nM).
Other Name: Goserelin
Experimental: APALUTAMIDE monotherapy
o APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets)
Drug: Apalutamide
APALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.
Experimental: Abiraterone acetate + Prednisone + APALUTAMIDE
  • Abiraterone administered at a single 1000 mg daily oral dose (4 x 250 mg tablets)
  • Prednisone administered at a 5 mg twice daily oral dose
  • APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets)
Drug: Apalutamide
APALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.
Drug: Abiraterone
Abiraterone acetate 1,000 mg (four 250 mg tablets) should be taken orally once daily, in combination with oral dose prednisone 5mg twice daily continuously. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days
Drug: Prednisone
Subjects will receive prednisone 10mg/day.
Category Value
Date last updated at source 10-Aug-16
Recruiting in Brazil
Study type(s) Randomised clinical trial
Expected enrolment 126
Study start date 01-Jan-17
Estimated primary completion date 01-Jan-20

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