The purpose of this study is to determine if the addition of apalutamide to ADT provides
superior efficacy in improving radiographic progression-free survival (rPFS) or overall
survival (OS) for participants with mHSPC.
Additional locations may be listed on ClinicalTrials.gov for NCT02489318.
Locations matching your search criteria
United States
New York
Bronx
Montefiore Medical Center-Weiler HospitalStatus: Active
Name Not Available
This is a randomized (study medication assigned to participants by chance), double-blind
(neither the researchers nor the participants know what treatment the participant is
receiving), placebo-controlled, multinational, multicenter study of apalutamide in
participants with mHSPC. The study consists of 4 Phases: Screening Phase (up to 28 days
before randomization), Treatment Phase (28 day treatment cycles until disease progression
or the occurrence of unacceptable treatment related toxicity), an End of Treatment Phase
(until 30 days after the last dose of study drug), and then a Survival Follow up Phase.
In the event of a positive study result and notification of unblinding at either of the
interim analyses or at the final analysis, participants in the treatment Phase will have
the opportunity to enroll in an Open-label Extension Phase, which will allow participants
to receive active drug (apalutamide) for approximately 3 years. Participants who are
receiving apalutamide in the Open-label Extension Phase may continue receiving
apalutamide in the Long-term Extension (LTE) Phase if they will continue to derive
benefit from treatment (based on investigator assessment). Participants' safety will be
monitored throughout the study.
Lead OrganizationAragon Pharmaceuticals, Inc.
