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Spots Global Cancer Trial Database for Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

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Trial Identification

Brief Title: Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

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

Study ID: NCT03348670

Conditions

Prostate Cancer

Study Description

Brief Summary: 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 RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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 ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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.

Detailed Description: 1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients. 2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients. 3. Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients. 4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy. 5. Correlate everyone patient drug target gene SNP to everyone patient drug safety. 6. 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). 7. Confirm the relationship between drug target gene SNPs and drug efficacy. 8. Confirm the relationship between drug target gene SNPs and drug safety.

Eligibility

Minimum Age: 22 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701, Rockville, Maryland, United States

Contact Details

Name: HAN XU, MD/PhD/FAPCR

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

Role: STUDY_CHAIR

Name: HAN XU, MD/PhD/FAPCR

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

Role: STUDY_DIRECTOR

Name: HAN XU, MD/PhD/FAPCR

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

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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