Phase 2
Completed N=82
A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT01685983 ↗Enrolled (actual)
82
Serious AEs
48.8%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Prostate-specific Antigen (PSA) Response — 42.7 Percentage of participants
Summary
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Prostate-specific Antigen (PSA) Response |
42.7 | — |
| SECONDARY Overall Survival |
538 | — |
| SECONDARY Time to PSA Progression |
141 | — |
| SECONDARY Percentage of Participants With Objective Radiographic Response |
6.1 | — |
| SECONDARY Serum Testosterone |
1.210; 1.210 | — |
| SECONDARY Dehydroepiandrosterone Sulfate (DHEA-S) |
0.725; 0.080 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
81; 40 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
- Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
- Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
- Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
- Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
- Eastern Cooperative Oncology Group Performance Status less than or equal to 2
Exclusion Criteria
- Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Uncontrolled hypertension
- Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
- Has abnormal liver function tests
- Surgery or local prostatic intervention within 30 days of the first dose
Data sourced from ClinicalTrials.gov (NCT01685983). 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. Informational only — not medical advice.