RecruitingPhase 2NCT03833921

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


Sponsor

Martha Mims

Enrollment

130 participants

Start Date

May 23, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether the race or ethnicity of a patient affects how well a hormone-blocking drug called abiraterone (combined with prednisone) works for men with prostate cancer that has spread (metastatic) and is being treated with hormone therapy for the first time. **You may be eligible if...** - You are a man with prostate cancer confirmed by biopsy or cytology - Your cancer has spread to soft tissue or bone (metastatic disease) - You have started hormone therapy (medical or surgical castration) no more than 42 days ago - You are willing to take abiraterone plus prednisone as part of your treatment - You have had recent imaging (bone scan or PET scan within 42 days) **You may NOT be eligible if...** - You have been on hormone therapy (castration) for more than 42 days for metastatic prostate cancer - You are not willing to continue or start hormone therapy alongside abiraterone - Your cancer has not been confirmed as metastatic - You have significant health conditions that prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAbiraterone Acetate

1000 mg orally daily until disease progression

DRUGPrednisone

5 mg oral low dose prednisone, twice daily


Locations(3)

Ben Taub General Hospital

Houston, Texas, United States

Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine

Houston, Texas, United States

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03833921


Related Trials