Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients

Sponsor
University of Athens
Study ID
NCT03173859
Phase
PHASE2
Status
Withdrawn

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

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

Interventions

  • Abiraterone — DRUG
    Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally
  • Apalutamide — DRUG
    apalutamide 240mg qD orally

Study Details

A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide

Key Dates

Start date
Jan 31, 2018
Status verified
Nov 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

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

Arms

  • Experimental: Rotational
    Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally starting on Day 1 of Cycle 1 for 3 cycles, followed by apalutamide 240mg qD orally for 3 cycles. The duration of each cycle is 28 days
  • Active Comparator: Sequential
    Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally starting on Day 1 of Cycle 1 until disease progression, followed by apalutamide 240mg qD orally until second disease progression.

Primary Outcome Measure

Radiographic progression-free survival [ Time Frame: Estimated up to 24 months ]

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