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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Apalutamide: Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.
Abiraterone acetate: Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Prednisone: Participants will receive 5 mg tablet of prednisone twice daily orally.
Placebo: Participants will receive matching placebo to apalutamide once daily orally.
Study summary
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 \[gland that makes fluid that aids movement of sperm\]).
Eligibility
Primary outcome measure(s)
- Radiographic Progression-free Survival (rPFS) — Up to 3 years and 4 months
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Trial sites (173)
| Facility | City | Region | Status |
|---|---|---|---|
| — | Phoenix | Arizona | |
| — | La Mesa | California | |
| — | Los Angeles | California | |
| — | Modesto | California | |
| — | San Diego | California | |
| — | San Francisco | California | |
| — | Santa Barbara | California | |
| — | Aurora | Colorado | |
| — | Denver | Colorado | |
| — | Jensen Beach | Florida | |
| — | Lakeland | Florida | |
| — | New Port Richey | Florida | |
| — | Ocala | Florida | |
| — | Atlanta | Georgia | |
| — | Melrose | Illinois | |
| — | Niles | Illinois | |
| — | Marrero | Louisiana | |
| — | New Orleans | Louisiana | |
| — | Shreveport | Louisiana | |
| — | Auburn | Maine | |
| — | Baltimore | Maryland | |
| — | St Louis | Missouri | |
| — | Omaha | Nebraska | |
| — | Las Vegas | Nevada | |
| — | Albany | New York | |
| — | Johnson City | New York | |
| — | New York | New York | |
| — | Poughkeepsie | New York | |
| — | Syracuse | New York | |
| — | The Bronx | New York | |
| — | Columbus | Ohio | |
| — | Tualatin | Oregon | |
| — | Lancaster | Pennsylvania | |
| — | Pittsburgh | Pennsylvania | |
| — | Charleston | South Carolina | |
| — | Myrtle Beach | South Carolina | |
| — | Nashville | Tennessee | |
| — | Austin | Texas | |
| — | Houston | Texas | |
| — | Norfolk | Virginia |
+ 133 more sites — see the full list on the official registry below.
On this site
📄 Deltasone (prednisone) drug profile →More Aragon Pharmaceuticals, Inc. trials in Australia
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 NCT02257736 on ClinicalTrials.gov ↗ ← All trials in Australia