Phase 2
Completed N=72
Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer
Metastatic Castration Resistant Prostate Cancer · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT01543776 ↗
Enrolled (actual)
72
Serious AEs
10.3%
Results posted
Jul 2019
Primary outcomePrimary: Change in PSA Level — -1.19; -1.59 log ratio — p=<0.10
Summary
This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PSA Level |
-1.19; -1.59 | <0.10 |
| SECONDARY Progression-free Survival (PFS) |
8.6; 8.6 | 0.38 |
| SECONDARY Adrenal Androgen Production (DHEA-S) |
13.30; 10.22 | 0.13 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
6; 11 | 0.26 |
| SECONDARY Peak Plasma Concentration of Abiraterone |
5.39; 4.65 | 0.012 sig |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed prostate cancer with progressive disease defined as either:
- 2 or more new lesions on bone scan or
- Progressive disease on computed tomography (CT)/magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria or
- Rising prostate-specific antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart
- Evidence of castration resistance defined as disease progression despite a testosterone level = 5 years from enrollment
- Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings < 160/100)
- Serum potassium (K)+ < 3.5 mmoL/L on more than one reading within the screening period
- Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
- Active psychiatric illness/social situations that would limit compliance with protocol requirements
- New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
- Concurrent therapy with strong inhibitors or inducers of Cytochrome P450 (CYP)3A4 due to concerning possible drug-drug interactions with abiraterone
Data sourced from ClinicalTrials.gov (NCT01543776). 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.