An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Aragon Pharmaceuticals, Inc.
Study ID
NCT02257736
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 240 mg (4\*60 mg tablets) of apalutamide once daily orally.
  • Abiraterone acetate — DRUG
    Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.
  • Prednisone — DRUG
    Participants will receive 5 mg tablet of prednisone twice daily orally.
  • Placebo — DRUG
    Participants will receive matching placebo to apalutamide once daily orally.

Study Details

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).

Key Dates

Start date
Nov 26, 2014
Status verified
Jun 2026
Primary completion
Mar 19, 2018
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Group 1: AAP and apalutamide
    Participants will receive apalutamide 240 milligram (mg) (4\*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).
  • Placebo Comparator: Group 2: AAP and Placebo
    Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).

Primary Outcome Measure

Radiographic Progression-free Survival (rPFS) [ Time Frame: Up to 3 years and 4 months ]

Locations (46)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-La MesaCalifornia--
-Los AngelesCalifornia--
-ModestoCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-Santa BarbaraCalifornia--
-AuroraColorado--
-DenverColorado--
-Jensen BeachFlorida--
-LakelandFlorida--
-New Port RicheyFlorida--
-OcalaFlorida--
-AtlantaGeorgia--
-MelroseIllinois--
-NilesIllinois--
-MarreroLouisiana--
-New OrleansLouisiana--
-ShreveportLouisiana--
-AuburnMaine--
-BaltimoreMaryland--
-St LouisMissouri--
-OmahaNebraska--
-Las VegasNevada--
-AlbanyNew York--
-Johnson CityNew York--
-New YorkNew York--
-PoughkeepsieNew York--
-SyracuseNew York--
-The BronxNew York--
-ColumbusOhio--
-TualatinOregon--
-LancasterPennsylvania--
-PittsburghPennsylvania--
-CharlestonSouth Carolina--
-Myrtle BeachSouth Carolina--
-NashvilleTennessee--
-AustinTexas--
-HoustonTexas--
-NorfolkVirginia--
-RichmondVirginia--
-AuburnWashington--
-SeattleWashington--
-SpokaneWashington--
-WenatcheeWashington--
-MadisonWisconsin--

Find similar trials in Phoenix, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

Related Studies