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

Sponsor
Latin American Cooperative Oncology Group
Study ID
NCT02867020
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    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.
  • Abiraterone — DRUG
    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
  • ADT — DRUG
    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).
  • Prednisone — DRUG
    Subjects will receive prednisone 10mg/day.

Study Details

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.

Key Dates

Start date
Oct 11, 2017
Status verified
Jul 2021
Primary completion
Oct 9, 2019
Completion
Jun 30, 2021

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • Experimental: APALUTAMIDE monotherapy
    o APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets)
  • 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)

Primary Outcome Measure

Number of patients that achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL [ Time Frame: Week 25 ]

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