Clinical trial · Interventional
Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
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
NCT01940276CI-TRIAL-00048721completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abiraterone Acetate and Prednisone
- description
- 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
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisone
Primary outcomes (1)
- measure
- Median Radiographic Progression Free Survival (PFS)
- timeFrame
- up to 2 years
- description
- 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 outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPiwarski SA, Howard LE, Paul MA, Bachelder N, LaCroix B, Clayton A, Allen D, Kephart J, Armstrong AJ, Patierno SR, George DJ, Hyslop T, Freedman JA. Genetic ancestry-concordant ceramide metabolism and response to androgen receptor pathway inhibition in metastatic castration-resistant prostate cancer. Cancer. 2026 Jun 1;132(11):e70371. doi: 10.1002/cncr.70371. PMID 42186347