- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01940276
Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
November 16, 2020 updated by: Duke University
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
The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Birmingham VA Medical Center
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Cancer Center
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Henderson, North Carolina, United States, 27536
- Maria Parham Medical Center
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Laurinburg, North Carolina, United States, 28352
- Scotland Memorial Hospital
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Lumberton, North Carolina, United States, 28359
- Southeastern Regional
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Raleigh, North Carolina, United States, 27609
- Duke Raleigh Hospital
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Salisbury, North Carolina, United States, 28144
- W. G. 'Bill' Hefner VA Medical Center
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Smithfield, North Carolina, United States, 27577
- Johnston Memorial Hospital
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University
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South Carolina
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Regional
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Virginia
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Hampton, Virginia, United States, 23666
- Virginia Oncology Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Radiographic Progression Free Survival (PFS)
Time Frame: up to 2 years
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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.
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PSA Response
Time Frame: Baseline and up to 2 years
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Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%
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Baseline and up to 2 years
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Median Time to PSA Progression
Time Frame: up to 2 years
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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.
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up to 2 years
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Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
Time Frame: up to 2 years
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Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml
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up to 2 years
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Percent of Subjects Experiencing Hypertension
Time Frame: up to 2 years
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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)
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up to 2 years
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Overall Survival
Time Frame: up to 3 years
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Length of patient's life after starting study
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up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2013
Primary Completion (Actual)
October 8, 2019
Study Completion (Actual)
October 8, 2019
Study Registration Dates
First Submitted
September 9, 2013
First Submitted That Met QC Criteria
September 11, 2013
First Posted (Estimate)
September 12, 2013
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- Pro00046383
- 212082PCR2018 (Other Identifier: Janssen)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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