A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Condition(s) studied
Investigational drug(s) / intervention(s)
Apalutamide: Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Placebo: Participants will receive Placebo orally once daily in each 28 day treatment cycles.
Androgen Deprivation Therapy (ADT): 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 summary
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.
Eligibility
Primary outcome measure(s)
- Radiographic Progression-free Survival (rPFS) — Up to 35 months
rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1. - Overall Survival (OS) — Up to 57 months
OS was defined as the time from date of randomization to date of death from any cause.
Trial sites (220)
| Facility | City | Region | Status |
|---|---|---|---|
| — | Homewood | Alabama | |
| — | Tucson | Arizona | |
| — | San Bernardino | California | |
| — | San Diego | California | |
| — | Denver | Colorado | |
| — | Norwalk | Connecticut | |
| — | Fort Myers | Florida | |
| — | Chicago | Illinois | |
| — | Fort Wayne | Indiana | |
| — | Jeffersonville | Indiana | |
| — | New Orleans | Louisiana | |
| — | Baltimore | Maryland | |
| — | Rockville | Maryland | |
| — | Lansing | Michigan | |
| — | Troy | Michigan | |
| — | Omaha | Nebraska | |
| — | Las Vegas | Nevada | |
| — | Brooklyn | New York | |
| — | Poughkeepsie | New York | |
| — | Syracuse | New York | |
| — | The Bronx | New York | |
| — | Raleigh | North Carolina | |
| — | Salisbury | North Carolina | |
| — | Cleveland | Ohio | |
| — | Middleburg Heights | Ohio | |
| — | Springfield | Oregon | |
| — | Bala-Cynwyd | Pennsylvania | |
| — | Bryn Mawr | Pennsylvania | |
| — | Lancaster | Pennsylvania | |
| — | Charleston | South Carolina | |
| — | Nashville | Tennessee | |
| — | Dallas | Texas | |
| — | Houston | Texas | |
| — | San Antonio | Texas | |
| — | Richmond | Virginia | |
| — | Virginia Beach | Virginia | |
| — | Burien | Washington | |
| — | Spokane | Washington | |
| — | Milwaukee | Wisconsin | |
| — | Berazategui | Argentina |
+ 180 more sites — see the full list on the official registry below.
More Aragon Pharmaceuticals, Inc. trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02489318 on ClinicalTrials.gov ↗ ← All trials in South Korea