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 (APRE)

NCT03833921 Phase 2 RECRUITING

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.

Details

Lead sponsor	Martha Mims
Phase	Phase 2
Status	RECRUITING
Enrolment	130
Start date	2019-05-23
Completion	2038-04

Conditions

• Prostate Cancer Metastatic
• Prostate Cancer

Interventions

• Abiraterone Acetate
• Prednisone

Primary outcomes

• PSA Response Rate — Treatment start until 7 months after start of ADT
  The proportion of subjects with PSA levels less than 4 ng/ml at the given time point.

Countries

United States