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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.
 
ClinicalTrials.gov Identifier: NCT01940276
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : November 14, 2019
Sponsor:
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.

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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: every 12 weeks, up to 2 years ]
    Radiographic PFS based on PCWG2 criteria or based on the onset of a skeletal related event. Imaging obtained every 12 weeks.


Secondary Outcome Measures :
  1. Change in radiologic response rates [ Time Frame: every 12 weeks, up to 2 years ]
    RECIST 1.1 defined radiologic response rates and incidence of bone flares

  2. Change in PSA response [ Time Frame: every 4 weeks, up to 2 years ]
    Duration of PSA response

  3. Time to PSA nadir [ Time Frame: every 4 weeks, up to 2 years ]
    Time to PSA nadir

  4. Percent of men who achieve a PSA < 0.1 [ Time Frame: every 4 weeks, up to 2 years ]
    Percent of men who achieve a PSA < 0.1

  5. Number of adverse events [ Time Frame: up to 2 years ]
    Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations

  6. Overall survival [ Time Frame: every 6 months after end of patient's study treatment, up to 5 years ]
    Length of patient's life after starting study



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

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 ClinicalTrials.gov identifier (NCT number): NCT01940276


Locations
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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
Investigators
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Principal Investigator: Daniel George, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01940276    
Other Study ID Numbers: Pro00046383
212082PCR2018 ( Other Identifier: Janssen )
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Keywords provided by Duke University:
Prostate cancer
metastatic
castrate resistant
abiraterone acetate
prednisone
metastatic prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
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