Study on How Race and Other Factors Affect Response to Abiraterone/Prednisone in Men with Metastatic Hormone-Naive Prostate Cancer

Sponsor: Martha Mims

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03833921

Provider View

This study is examining how race and ethnicity might influence the effectiveness of standard treatments for men with metastatic hormone-naive prostate cancer. Participants will receive the usual care with abiraterone acetate and prednisone, and will be followed for up to 10 years to observe treatment responses.

Patient Parameters

Program Overview

The study aims to understand if there is a link between race, ethnicity, and how well standard treatments work for men with metastatic hormone-naive prostate cancer. Participants will receive standard care with abiraterone acetate and prednisone, and researchers will track their progress over a period of up to 10 years.

Description

This study involves men with metastatic hormone-naive prostate cancer who are receiving standard treatment. Typically, these men are offered androgen deprivation therapy (ADT) combined with abiraterone acetate and low-dose prednisone, or ADT with docetaxel and prednisone for those with a higher tumor burden. However, many opt for abiraterone due to fewer side effects compared to chemotherapy.

The study plans to enroll about 130 men, with an expected 50% being African American based on previous clinic experiences. Participants must have started ADT within 42 days of joining the study and will continue with ADT throughout. Abiraterone acetate and low-dose prednisone will be administered until the cancer progresses according to specific criteria.

The study will help determine if race and ethnicity affect how well these treatments work, providing valuable insights for future care strategies.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer that has spread to other parts of the body.
  • Must have started androgen deprivation therapy (ADT) within 42 days before joining the study.
  • Must be willing to continue ADT and switch to abiraterone acetate and prednisone if currently on other medications.
  • Must have had no more than 42 days of prior castration for metastatic prostate cancer.
  • Must have adequate liver, kidney, and blood function as shown by specific tests.
  • Must have a PSA level of at least 10 ng/mL within 90 days before joining the study.
  • Must be 18 years or older and able to provide informed consent.
  • Must not have any other active cancer, except for certain skin cancers or cancers in remission for 5 years.

Exclusion Criteria

  • Must not have brain metastases.
  • Must not be taking or planning to take certain medications like ketoconazole or enzalutamide.
  • Must not have received chemotherapy for metastatic prostate cancer.
  • Must not have severe heart conditions or recent heart issues.
  • Must not have a history of adrenal insufficiency.
  • Must not have allergies to study medications.
  • Must not have gastrointestinal issues that affect medication absorption.

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