Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer
Martha Mims
Summary
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.
Description
This is a single arm study in metastatic hormone naïve prostate cancer. Standard of care in these men is either to offer Androgen deprivation therapy (ADT) + abiraterone acetate/low-dose prednisone or, in men with higher tumor burden, to offer ADT + Docetaxel/prednisone. The investigator\'s experience is that even men with increased tumor burden often opt for abiraterone because of the improved side effect protocol as compared to chemotherapy. Approximately 130 PSA response evaluable subjects will be enrolled, of which the investigators expect 50% to be African American based on clinic po…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. All patients must have metastatic disease as evidenced by soft tissue and/or bony metastases prior to initiation of androgen deprivation therapy (ADT). NOTE: ADT does not include treatment with anti-androgens such as bicalutamide or flutamide or five alpha reductase inhibitors such as finasteride or dutasteride. * Patients must have radiographic assessments of all disease including bone scan (or PET scan) within 42 days prior to registration. All disease will be a…
Interventions
- DrugAbiraterone Acetate
1000 mg orally daily until disease progression
- DrugPrednisone
5 mg oral low dose prednisone, twice daily
Locations (3)
- Ben Taub General HospitalHouston, Texas
- Dan L. Duncan Comprehensive Cancer Center at Baylor College of MedicineHouston, Texas
- Michael E. DeBakey Veterans Affairs Medical CenterHouston, Texas