Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT00887198
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Abiraterone acetate — DRUG
    1000 mg per day (4 x 250-mg tablets) taken orally.
  • Placebo — DRUG
    4 placebo tablets per day taken orally.
  • Prednisone — DRUG
    5 mg tablet orally twice daily.

Study Details

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

Key Dates

Start date
Apr 28, 2009
Status verified
Jan 2025
Primary completion
Mar 31, 2014
Completion
May 25, 2017

Study Design

Enrollment
1,088 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo + prednisone
    Placebo plus prednisone
  • Experimental: Abiraterone + prednisone
    Abiraterone acetate plus prednisone

Primary Outcome Measure

Overall Survival [ Time Frame: From randomization (Day 1) up to end of study (Month 60) ]

Locations (48)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-TucsonArizona--
-BellflowerCalifornia--
-Los AngelesCalifornia--
-Marina del ReyCalifornia--
-SacramentoCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-StanfordCalifornia--
-AuroraColorado--
-New HavenConnecticut--
-Boca RatonFlorida--
-Fort MyersFlorida--
-GainesvilleFlorida--
-AtlantaGeorgia--
-HonoluluHawaii--
-Kansas CityKansas--
-MetairieLouisiana--
-New OrleansLouisiana--
-BaltimoreMaryland--
-BostonMassachusetts--
-DearbornMichigan--
-Saint Louis ParkMinnesota--
-St LouisMissouri--
-BillingsMontana--
-OmahaNebraska--
-Las VegasNevada--
-East SyracuseNew York--
-New Hyde ParkNew York--
-New YorkNew York--
-SyracuseNew York--
-DurhamNorth Carolina--
-RaleighNorth Carolina--
-CantonOhio--
-ClevelandOhio--
-PortlandOregon--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--
-ColumbiaSouth Carolina--
-Myrtle BeachSouth Carolina--
-ChattanoogaTennessee--
-NashvilleTennessee--
-DallasTexas--
-HoustonTexas--
-San AntonioTexas--
-NorfolkVirginia--
-SeattleWashington--
-MadisonWisconsin--

Find similar trials in Birmingham, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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