The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Birmingham VA Medical Center
Birmingham, Alabama, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Karmanos Cancer Institute
Median Radiographic Progression Free Survival (PFS)
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.
Time frame: up to 2 years
Change in PSA Response
Percent of men with Prostate Specific Antigen (PSA) declines \> 30%, \> 50% and \> 90%
Time frame: Baseline and up to 2 years
Median Time to PSA Progression
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.
Time frame: up to 2 years
Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
Number of men who achieve a PSA decline to \< 0.1 and \< 0.2 ng/ml
Time frame: up to 2 years
Percent of Subjects Experiencing Hypertension
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)
Time frame: up to 2 years
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Detroit, Michigan, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Maria Parham Medical Center
Henderson, North Carolina, United States
Scotland Memorial Hospital
Laurinburg, North Carolina, United States
Southeastern Regional
Lumberton, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
W. G. 'Bill' Hefner VA Medical Center
Salisbury, North Carolina, United States
...and 4 more locations
Overall Survival
Length of patient's life after starting study
Time frame: up to 3 years