A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Aragon Pharmaceuticals, Inc.
Study ID
NCT02489318
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
  • Placebo — DRUG
    Participants will receive Placebo orally once daily in each 28 day treatment cycles.
  • Androgen Deprivation Therapy (ADT) — DRUG
    All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Study Details

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.

Key Dates

Start date
Nov 27, 2015
Status verified
Jun 2026
Primary completion
Sep 7, 2020
Completion
Dec 31, 2027

Study Design

Enrollment
1,052 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide plus ADT
    Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
  • Experimental: Placebo plus ADT
    Participants will receive matching Placebo with ADT.

Primary Outcome Measure

Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to 35 months ]

Locations (39)

FacilityCityStateZIPSite coordinators
-HomewoodAlabama--
-TucsonArizona--
-San BernardinoCalifornia--
-San DiegoCalifornia--
-DenverColorado--
-NorwalkConnecticut--
-Fort MyersFlorida--
-ChicagoIllinois--
-Fort WayneIndiana--
-JeffersonvilleIndiana--
-New OrleansLouisiana--
-BaltimoreMaryland--
-RockvilleMaryland--
-LansingMichigan--
-TroyMichigan--
-OmahaNebraska--
-Las VegasNevada--
-BrooklynNew York--
-PoughkeepsieNew York--
-SyracuseNew York--
-The BronxNew York--
-RaleighNorth Carolina--
-SalisburyNorth Carolina--
-ClevelandOhio--
-Middleburg HeightsOhio--
-SpringfieldOregon--
-Bala-CynwydPennsylvania--
-Bryn MawrPennsylvania--
-LancasterPennsylvania--
-CharlestonSouth Carolina--
-NashvilleTennessee--
-DallasTexas--
-HoustonTexas--
-San AntonioTexas--
-RichmondVirginia--
-Virginia BeachVirginia--
-BurienWashington--
-SpokaneWashington--
-MilwaukeeWisconsin--

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