Phase 2
Completed N=58
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Source: ClinicalTrials.gov NCT00485303 ↗Enrolled (actual)
58
Serious AEs
39.7%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Participants With Prostate Specific Antigen (PSA) Response — 37.9 percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Prostate Specific Antigen (PSA) Response |
37.9 | — |
| SECONDARY Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS) |
141 | — |
| SECONDARY Radiographic Progression Free Survival (PFS) |
126 | — |
| SECONDARY Overall Survival (OS) |
492 | — |
| SECONDARY Percentage of Participants With Objective Radiographic Response |
0; 6.3 | — |
| SECONDARY Time to PSA Progression |
169 | — |
| SECONDARY Time to Radiographic Progression |
88 | — |
| SECONDARY Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
22; 2; 0; 0; 0; 14 | — |
| SECONDARY Percentage of Participants With Clinical Benefit |
12; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
- Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
- Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria
- Ongoing androgen deprivation with serum testosterone less than ( = 50 percent)
Exclusion Criteria
- Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Uncontrolled hypertension (high blood pressure)
- Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion support
- Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function
Data sourced from ClinicalTrials.gov (NCT00485303). 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.