Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01940276
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Information provided by (Responsible Party):
Duke University

Brief Summary:
The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Abiraterone acetate Drug: Prednisone Phase 2

Detailed Description:
This is a non-comparative pilot open-label, parallel arm, multicenter study of abiraterone acetate in African American and Caucasian men with mCRPC. Patients will self-report on race and 50 patients will be enrolled into each group. Patients will be treated on open-label treatment until evidence of disease progression as defined by Prostate Cancer Working Group Two (PCWG2) definition or until two years at which point they will roll over to the standard of care at that time. The study agent abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles throughout the treatment period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer
Actual Study Start Date : October 2013
Actual Primary Completion Date : October 8, 2019
Actual Study Completion Date : October 8, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Abiraterone Acetate and Prednisone
abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles
Drug: Abiraterone acetate
Other Name: Zytiga

Drug: Prednisone

Primary Outcome Measures :
  1. Median Radiographic Progression Free Survival (PFS) [ Time Frame: up to 2 years ]
    Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.

Secondary Outcome Measures :
  1. Change in PSA Response [ Time Frame: Baseline and up to 2 years ]
    Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%

  2. Median Time to PSA Progression [ Time Frame: up to 2 years ]
    Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.

  3. Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml [ Time Frame: up to 2 years ]
    Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml

  4. Percent of Subjects Experiencing Hypertension [ Time Frame: up to 2 years ]
    Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)

  5. Overall Survival [ Time Frame: up to 3 years ]
    Length of patient's life after starting study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male, age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Life expectancy of ≥ 12 months
  • Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken, and should be able to swallow tablets whole, without crushing/chewing tablets
  • Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
  • Adequate laboratory parameters
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are excluded
  • Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone only metastasis are permitted
  • Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. Screening serum testosterone must be <50 ng/dl
  • PSA ≥ 2.0 ng/mL
  • Evidence of of castration resistant disease on ADT as evidenced by one of the following:

    • Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
    • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
    • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified PCWG2 criteria or modified RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies)
  • A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
  • A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug
  • A minimum of 4 weeks from any major surgery prior to start of study drug
  • Self-reported race of either African American or Caucasian
  • Ability to swallow, retain, and absorb oral medication

Exclusion Criteria:

  • Prior treatment with abiraterone acetate or enzalutamide
  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid
  • Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Symptomatic Liver or visceral organ metastasis
  • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Known brain metastasis
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Poorly controlled diabetes
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
  • Atrial Fibrillation or other cardiac arrhythmia requiring therapy
  • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
  • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01940276

Layout table for location information
United States, Alabama
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
United States, Louisiana
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Maria Parham Medical Center
Henderson, North Carolina, United States, 27536
Scotland Memorial Hospital
Laurinburg, North Carolina, United States, 28352
Southeastern Regional
Lumberton, North Carolina, United States, 28359
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
W. G. 'Bill' Hefner VA Medical Center
Salisbury, North Carolina, United States, 28144
Johnston Memorial Hospital
Smithfield, North Carolina, United States, 27577
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Spartanburg Regional
Spartanburg, South Carolina, United States, 29303
United States, Virginia
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Duke University
Layout table for investigator information
Principal Investigator: Daniel George, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] March 3, 2018

Layout table for additonal information
Responsible Party: Duke University Identifier: NCT01940276    
Other Study ID Numbers: Pro00046383
212082PCR2018 ( Other Identifier: Janssen )
First Posted: September 12, 2013    Key Record Dates
Results First Posted: December 9, 2020
Last Update Posted: December 9, 2020
Last Verified: November 2020
Keywords provided by Duke University:
Prostate cancer
castrate resistant
abiraterone acetate
metastatic prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Abiraterone Acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors