Study on How Genetic Differences Affect the Effectiveness and Safety of Abiraterone in Prostate Cancer Treatment

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Sponsor score: 0

ClinicalTrials ID:NCT03348670

Provider View

This clinical trial is exploring how genetic variations in patients with prostate cancer might influence the effectiveness and safety of the drug Abiraterone, used in combination with other medications. The study involves analyzing specific genetic markers to understand their impact on treatment outcomes.

Patient Parameters

Program Overview

The purpose of this study is to investigate whether certain genetic differences, known as single nucleotide polymorphisms (SNPs), affect how well the drug Abiraterone works and how safe it is for patients with prostate cancer. Researchers will look at two specific genes, CYP17 and SULT2A1, to see if variations in these genes influence the treatment's effectiveness and safety. The study involves 600 prostate cancer patients who will receive a combination of Abiraterone, prednisone, and Bicalutamide. Participants' genetic information will be analyzed to find any links between these genetic markers and the treatment outcomes.

Description

This study involves 600 prostate cancer patients who will be randomly divided into two groups. Each group will receive a combination of Abiraterone, prednisone, and Bicalutamide. Researchers will collect genetic information from all participants to identify specific genetic variations, known as SNPs, in two genes: CYP17 and SULT2A1. These genes are thought to play a role in how the body processes Abiraterone.

The study aims to:

  1. Analyze the complete genetic sequence of each participant to identify SNPs.
  2. Compare the genetic sequences of all participants to find common SNPs.
  3. Determine if these SNPs are linked to how well Abiraterone works in treating prostate cancer.
  4. Assess if these SNPs are related to any side effects or safety concerns associated with the treatment.
  5. Compare the genetic data between the two groups to confirm any relationships between SNPs and treatment outcomes.

By understanding these genetic differences, researchers hope to improve the effectiveness and safety of Abiraterone for prostate cancer patients.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer.
  • Cancer is confined to the prostate.
  • Have not had surgery to remove the prostate or testicles.
  • Must stop any previous chemotherapy treatments.
  • No other types of cancer present.
  • Willing to sign a consent form and provide blood samples.

Exclusion Criteria

  • Currently receiving other cancer treatments that cannot be stopped.
  • Have other serious illnesses or infections.
  • Have more than one type of cancer.
  • Have severe drug allergies or bleeding disorders.
  • Have experienced serious side effects from similar drugs.
  • Cannot take the study drugs due to safety concerns.
  • No therapeutic benefit from the treatment.

Locations

FACILITYZIPCITYSTATE
Medicine Invention Design, Inc. - IORG0007849 - NPI-102338770120853RockvilleMaryland

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