Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01940276 |
Recruitment Status :
Completed
First Posted : September 12, 2013
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Drug: Abiraterone acetate Drug: Prednisone | Phase 2 |
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 |

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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Drug: Abiraterone acetate
Other Name: Zytiga Drug: Prednisone |
- 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.
- 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%
- 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.
- 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
- 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)
- Overall Survival [ Time Frame: up to 3 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 |
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
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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

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
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 |
Principal Investigator: | Daniel George, MD | Duke University |
Documents provided by Duke University:
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 |
Results First Posted: | December 9, 2020 |
Last Update Posted: | December 9, 2020 |
Last Verified: | November 2020 |
Prostate cancer metastatic castrate resistant |
abiraterone acetate prednisone metastatic prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms 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 |