A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Aragon Pharmaceuticals, Inc.
Study ID
NCT01946204
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    240 mg tablets administered by mouth on a continuous once daily dosing regimen
  • Placebo — DRUG
    Matched placebo tablets administered by mouth on a continuous once daily dosing regimen

Study Details

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Key Dates

Start date
Oct 14, 2013
Status verified
Jun 2026
Primary completion
May 19, 2017
Completion
Dec 31, 2027

Study Design

Enrollment
1,207 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A: Apalutamide
  • Placebo Comparator: Treatment Arm B: Placebo

Primary Outcome Measure

Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 43 Months ]

Locations (122)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-AnchorageAlaska--
-ChandlerArizona--
-TucsonArizona--
-DuarteCalifornia--
-FullertonCalifornia--
-Laguna WoodsCalifornia--
-Los AngelesCalifornia--
-OrangeCalifornia--
-RosevilleCalifornia--
-SacramentoCalifornia--
-San BernardinoCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-Santa MonicaCalifornia--
-Sherman OaksCalifornia--
-StanfordCalifornia--
-TarzanaCalifornia--
-TorranceCalifornia--
-DenverColorado--
-EnglewoodColorado--
-Glenwood SpringsColorado--
-Grand JunctionColorado--
-Washington D.C.District of Columbia--
-AventuraFlorida--
-Boca RatonFlorida--
-BradentonFlorida--
-Daytona BeachFlorida--
-Fort MyersFlorida--
-HialeahFlorida--
-JacksonvilleFlorida--
-MiamiFlorida--
-New Port RicheyFlorida--
-OrlandoFlorida--
-SarasotaFlorida--
-St. PetersburgFlorida--
-WellingtonFlorida--
-MeridianIdaho--
-ChicagoIllinois--
-DecaturIllinois--
-MaywoodIllinois--
-Melrose ParkIllinois--
-CarmelIndiana--
-JeffersonvilleIndiana--
-MuncieIndiana--
-West Des MoinesIowa--
-WestwoodKansas--
-WichitaKansas--
-MetairieLouisiana--
-New OrleansLouisiana--
-AnnapolisMaryland--
-BaltimoreMaryland--
-RockvilleMaryland--
-TowsonMaryland--
-BostonMassachusetts--
-DetroitMichigan--
-LansingMichigan--
-MinneapolisMichigan--
-Royal OakMichigan--
-DuluthMinnesota--
-Bay Saint LouisMississippi--
-SouthavenMississippi--
-Kansas CityMissouri--
-MissoulaMontana--
-OmahaNebraska--
-Las VegasNevada--
-HooksettNew Hampshire--
-HackensackNew Jersey--
-LawrencevilleNew Jersey--
-MorristownNew Jersey--
-Mount LaurelNew Jersey--
-New BrunswickNew Jersey--
-Voorhees TownshipNew Jersey--
-AlbuquerqueNew Mexico--
-AlbanyNew York--
-MineolaNew York--
-New YorkNew York--
-OneidaNew York--
-PoughkeepsieNew York--
-SyracuseNew York--
-The BronxNew York--
-ConcordNorth Carolina--
-GreensboroNorth Carolina--
-GreenvilleNorth Carolina--
-SalisburyNorth Carolina--
-Winston-SalemNorth Carolina--
-CincinnatiOhio--
-ClevelandOhio--
-Middleburg HeightsOhio--
-MiddletownOhio--
-BendOregon--
-PortlandOregon--
-TualatinOregon--
-Bala-CynwydPennsylvania--
-Bryn MawrPennsylvania--
-LancasterPennsylvania--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--
-WarwickRhode Island--
-CharlestonSouth Carolina--
-GreenvilleSouth Carolina--
-Myrtle BeachSouth Carolina--
-West ColumbiaSouth Carolina--
-MemphisTennessee--
-NashvilleTennessee--
-AbileneTexas--
-AmarilloTexas--
-DallasTexas--
-Fort Sam HoustonTexas--
-HoustonTexas--
-McAllenTexas--
-San AntonioTexas--
-NorfolkVirginia--
-RichmondVirginia--
-Virginia BeachVirginia--
-BurienWashington--
-EdmondsWashington--
-SeattleWashington--
-TacomaWashington--
-Green BayWisconsin--
-MadisonWisconsin--
-MilwaukeeWisconsin--

Find similar trials in Birmingham, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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