An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Aragon Pharmaceuticals, Inc.
Study ID
NCT02531516
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
  • Bicalutamide — DRUG
  • Bicalutamide Placebo — DRUG
  • Apalutamide Placebo — DRUG
  • GnRH (agonist) — DRUG
  • 74-80 Grays (units of radiation) — RADIATION

Study Details

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).

Key Dates

Start date
Nov 19, 2015
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Dec 29, 2028

Study Design

Enrollment
1,503 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide
    Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
  • Active Comparator: Control group
    Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Primary Outcome Measure

Metastasis-Free Survival (MFS) [ Time Frame: 108 Months ]

Locations (60)

FacilityCityStateZIPSite coordinators
-HomewoodAlabama--
-ChandlerArizona--
-ScottsdaleArizona--
-TucsonArizona--
-BakersfieldCalifornia--
-Los AngelesCalifornia--
-OrangeCalifornia--
-San BernardinoCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-AuroraColorado--
-DenverColorado--
-MiddleburyConnecticut--
-BradentonFlorida--
-Daytona BeachFlorida--
-Fort MyersFlorida--
-HialeahFlorida--
-Lakewood RchFlorida--
-NaplesFlorida--
-PlantationFlorida--
-MeridianIdaho--
-Evergreen ParkIllinois--
-HarveyIllinois--
-JeffersonvilleIndiana--
-WichitaKansas--
-AshlandKentucky--
-New OrleansLouisiana--
-ShreveportLouisiana--
-ScarboroughMaine--
-BaltimoreMaryland--
-BostonMassachusetts--
-St LouisMissouri--
-MorristownNew Jersey--
-AlbanyNew York--
-BrooklynNew York--
-New YorkNew York--
-PoughkeepsieNew York--
-RochesterNew York--
-SyracuseNew York--
-The BronxNew York--
-CaryNorth Carolina--
-RaleighNorth Carolina--
-PortlandOregon--
-SpringfieldOregon--
-Bala-CynwydPennsylvania--
-Bryn MawrPennsylvania--
-LancasterPennsylvania--
-PhiladelphiaPennsylvania--
-East GreenwichRhode Island--
-CharlestonSouth Carolina--
-Myrtle BeachSouth Carolina--
-NashvilleTennessee--
-DallasTexas--
-HoustonTexas--
-San AntonioTexas--
-FairfaxVirginia--
-Virginia BeachVirginia--
-BurienWashington--
-SpokaneWashington--
-MorgantownWest Virginia--

Find similar trials in Homewood, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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