Phase 3
N=1,088
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00887198 ↗Enrolled (actual)
1,088
Serious AEs
35.0%
Results posted
Apr 2015
Primary outcome: Primary: Overall Survival — 34.66; 30.29 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Abiraterone acetate (Drug); Placebo (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
34.66; 30.29 | — |
| PRIMARY Radiographic Progression-free Survival (rPFS) |
NA; 8.28 | — |
| SECONDARY Time to Opiate Use for Prostate Cancer Pain |
33.38; 23.39 | — |
| SECONDARY Time to Initiation of Cytotoxic Chemotherapy |
25.17; 16.82 | — |
| SECONDARY Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point |
12.29; 10.87 | — |
| SECONDARY Time to Prostate-specific Antigen (PSA) Progression |
11.07; 5.55 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
541; 524; 93; 208; 148; 39 | — |
| SECONDARY Mean Plasma Concentrations of Abiraterone |
— | — |
| SECONDARY Maximum Plasma Concentrations of Abiraterone |
— | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity]) |
— | — |
| SECONDARY Elimination Half-Life (t1/2) |
— | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Metastatic castration-resistant prostate cancer (CRPC)
- Previous anti-androgen therapy and progression after withdrawal
- ECOG performance status of either 0 or 1
- Medical or surgical castration with testosterone less than 50 ng/dL
- Life expectancy of at least 6 months
Exclusion Criteria
- Prior cytotoxic chemotherapy or biologic therapy for CRPC
- Prior ketoconazole for prostate cancer
- Known brain metastasis or visceral organ metastasis
- Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Data sourced from ClinicalTrials.gov (NCT00887198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.