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Active, Not Recruiting

NCT Number: NCT03348670

Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

22 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Rockville, Maryland, 20853, United States

About this study

  • Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients.
  • Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients.
  • Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients.
  • Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
  • Correlate everyone patient drug target gene SNP to everyone patient drug safety.
  • Mutually compare the usual approach group SNPs (300 double blind random group separated prostate cancer patients) with the study approach group SNPs (300 double blind random group separated prostate cancer patients).
  • Confirm the relationship between drug target gene SNPs and drug efficacy.
  • Confirm the relationship between drug target gene SNPs and drug safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Select 600 localized Prostate Cancer Patients without prostate resection
  • Dosage Duration at least 90 days
  • The usual approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, like as the usual approach group.
  • The study approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, like as the study approach group.

Inclusion criteria

  • Clinical diagnosis of Prostate Cancer (PC)
  • Cancer in the prostate only
  • Prior therapy without orchiectomy
  • Prior therapy without prostate resection
  • Prior different chemotherapy must-need stop
  • Have no other cancer at the same time
  • Sign an informed consent form
  • Receive blood-drawing

Exclusion criteria

  • Treatment with other anti-cancer therapies and the therapies cannot be stopped currently
  • The patients with other serious intercurrent illness or infectious diseases
  • Have more than one different kind of cancer at the same time
  • Serious Allergy to Drugs
  • Serious Bleed Tendency
  • Serious Risks or Serious Adverse Events of the drug product label
  • Serious Risks or Serious Adverse Events of NCI Table of Side Effects
  • The prohibition of drug products
  • Have no therapeutic effects
  • Follow up to the most current label and plan for safety monitoring

Treatment and study plan

Abiraterone - Usual

Drug
  • Oral
  • Abiraterone Combined Chemotherapy

Other names: ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral

Abiraterone - Study

Drug
  • Oral
  • Abiraterone Combined Chemotherapy

Other names: China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet for Oral

Primary outcomes

  1. Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

    Time frame: Up to 12 weeks

    • Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on ZYTIGA - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the usual approach group.
    • Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on China Import - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the study approach group.
    • Measure above every PC patient specific Abiraterone drug target (CYP17) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
    • Report every PC patient specific CYP17 SNP genotype in whole genome DNA sequence.
    • Measure above every PC patient specific Abiraterone drug target (SULT2A1) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
    • Report every PC patient specific SULT2A1 SNP genotype in whole genome DNA sequence.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.

Acronym: Drugs-SNPs

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2017
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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