NCT03833921

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Martha Mims · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 population and previous experience with clinical trial enrollment. The study will enroll men with newly diagnosed hormone naïve prostate cancer within 42 days of receiving the first dose of ADT (LHRH agonist or antagonist) or undergoing orchiectomy. Patients will continue ADT throughout the study. Abiraterone acetate and low dose prednisone will continue until progression as defined by standard PCWG2 criteria.

Conditions

• Prostate Cancer Metastatic
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	1000 mg orally daily until disease progression
DRUG	Prednisone	5 mg oral low dose prednisone, twice daily

Timeline

• Start date: 2019-05-23
• Primary completion: 2028-11-01
• Completion: 2038-04-01
• First posted: 2019-02-07
• Last updated: 2025-12-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study