Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

PHASE2CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

October 11, 2017

Primary Completion Date

October 9, 2019

Study Completion Date

June 30, 2021

Conditions
Prostate Cancer
Interventions
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).

DRUG

Prednisone

Subjects will receive prednisone 10mg/day.

Trial Locations (14)

Unknown

CRIO, Fortaleza

Clínica AMO, Salvador

Hospital Erasto Gaertner, Curitiba

Liga Norte Riograndense de Oncologia, Natal

Hospital de Caridade de Ijuí, Ijuí

CPO - Pucrs, Porto Alegre

Hospital de Câncer de Barretos, Barretos

Centro de Pesquisa Clínica em Hematologia e Oncologia - CEPHO, Santo André

Grupo COI, Rio de Janeiro

Beneficiencia Portuguesa de São Paulo/Hospital São José, São Paulo

Hospital Israelita Albert Einstein, São Paulo

IBCC, São Paulo

ICESP, São Paulo

22281 100

Oncologia Rede D'Or S.A., Rio de Janeiro

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER