OncoMatch/Clinical Trials/NCT03833921
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
Is NCT03833921 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Abiraterone Acetate and Prednisone for prostate cancer metastatic.
Treatment: Abiraterone Acetate · Prednisone — The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
must have metastatic disease as evidenced by soft tissue and/or bony metastases prior to initiation of androgen deprivation therapy (ADT)
Performance status
ZUBROD 0–2
Prior therapy
Must have received: androgen deprivation therapy (LHRH agonist, LHRH antagonist, orchiectomy) — metastatic
no more than 42 days of prior castration (medical or surgical) for metastatic prostate cancer prior to starting abiraterone
Cannot have received: cytotoxic chemotherapy
Exception: allowed if given with curative intent in neoadjuvant or adjuvant setting and at least 2 years have elapsed since completion
must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed. At least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting.
Cannot have received: ketoconazole (ketoconazole)
must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole
Cannot have received: aminoglutethimide (aminoglutethimide)
must not have received prior and/or must not have any plans for receiving concomitant therapy with aminoglutethimide
Cannot have received: androgen receptor inhibitor (enzalutamide)
must not have received prior and/or must not have any plans for receiving concomitant therapy with ... enzalutamide (MDV3100)
Lab requirements
Blood counts
leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL
Kidney function
calculated creatinine clearance ≥ 40 mL/min using a serum creatinine or by 24-hour urine creatinine (using Cockroft-Gault equation)
Liver function
bilirubin ≤ 2 x institutional upper limit of normal (ULN), and SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present
Cardiac function
QTc interval < 461 msec on the 12 lead ECG within 42 days prior to registration. Patients with asymptomatic or incidental bundle branch blocks may have QTc measured by a cardiologist or standard formulas such as Bazett's or Fridericia's to adjust for pre-existing blocks.
adequate hepatic function ... bilirubin ≤ 2 x institutional upper limit of normal (ULN), and SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present; adequate renal function ... calculated creatinine clearance ≥ 40 mL/min ...; adequate hematologic function ... leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL; QTc interval < 461 msec on the 12 lead ECG
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ben Taub General Hospital · Houston, Texas
- Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine · Houston, Texas
- Michael E. DeBakey Veterans Affairs Medical Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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