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Abiraterone Acetate in Treating Patients with Hormone-Resistant Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActiveNot specified11-0709
NCI-2012-00116, NCT01543776

Trial Description


This randomized pilot clinical trial studies the best way to give abiraterone acetate in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of androgen made by the body.

Further Study Information


I. To compare the pharmacodynamic effect of reduced dose (250 mg daily) abiraterone acetate in the prandial state (250 mg-Fed) to the full, standard 1000 mg daily dose in the fasting state (1000 mg-Fasting) as assessed by change in serum prostate-specific antigen (PSA).


I. To evaluate the effect of prandial states on plasma levels and the intra-patient pharmacokinetic variability of abiraterone acetate.

II. To evaluate the safety profile of reduced dose abiraterone acetate taken in the prandial state.

III. To evaluate the pharmacodynamic effect of reduced dose abiraterone acetate in the prandial state as assessed by reduction in the extra-gonadal androgen dehydroepiandrosterone sulfate (DHEA-S) and dehydroepiandrostenedione (DHEA).

IV. To evaluate the effect of prandial state on time to disease progression (Working group criteria).

V. To assess and describe medication adherence to abiraterone acetate for both dosing schedules.

OUTLINE: Patients are randomized to one of two treatment arms.

ARM I: Patients receive abiraterone acetate orally (PO) daily first thing in morning after an overnight fast of at least 8 hours and prednisone PO twice daily (BID).

ARM II: Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast and prednisone as in Arm I.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 30 days.

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 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 < 50 ng/dL (or surgical castration)

Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required

Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug

Denosumab or zoledronic acid are allowed

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Total bilirubin =< 1.5 x the upper limit of normal

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drug

Therapy with supplements or complementary is excluded with the following exceptions; all other supplements must be discontinued prior to initiation of study drug

Conventional multivitamin supplements



Soy supplements

Inability to swallow capsules or known gastrointestinal malabsorption

History of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 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; patients with a K+ < 3.5 mmoL/L are required to have a documented subsequent K+ > 3.5 prior to enrollment to be eligible

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 family 3, subfamily A, polypeptide 4 (CYP3A4) due to concerning possible drug-drug interactions with abiraterone

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

University of Chicago Comprehensive Cancer Center

  • National Cancer Institute
Russell Zelig Szmulewitz, Principal Investigator

Trial Sites



Emory University/Winship Cancer Institute

Bradley Curtis Carthon
Ph: 404-778-1868

Bradley Curtis Carthon
Principal Investigator


Northwestern University

Timothy M. Kuzel
Ph: 312-695-6180

Timothy M. Kuzel
Principal Investigator

University of Chicago Comprehensive Cancer Center

Russell Zelig Szmulewitz
Ph: 773-702-7609

Russell Zelig Szmulewitz
Principal Investigator


NorthShore University HealthSystem-Evanston Hospital

Bruce E. Brockstein
Ph: 847-570-1381

Bruce E. Brockstein
Principal Investigator


Ingalls Memorial Hospital

Mark Farrell Kozloff
Ph: 708-915-6747

Mark Farrell Kozloff
Principal Investigator


Illinois CancerCare-Peoria

Sachdev P. Thomas
Ph: 309-243-3000

Sachdev P. Thomas
Principal Investigator


Southern Illinois University School of Medicine

John E. Godwin
Ph: 503-215-6412

John E. Godwin
Principal Investigator

Fort Wayne

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Sreenivasa R. Nattam
Ph: 260-484-8830

Sreenivasa R. Nattam
Principal Investigator


National Cancer Institute

William Douglas Figg
Ph: 301-402-3623

Wei Peng Yong
Principal Investigator

Ann Arbor

University of Michigan Comprehensive Cancer Center

Maha H. A. Hussain
Ph: 800-865-1125

Maha H. A. Hussain
Principal Investigator

Link to the current record.
NLM Identifier NCT01543776

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.