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

Study Overview
=================
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
-----------------
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Abiraterone - Usual
* Drug: Abiraterone - Study


Participation Criteria
=================
Eligibility Criteria
-----------------
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 High Dose on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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 Low Dose on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, 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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The usual approach group (high dose) The study approach group (low dose)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abiraterone - Usual<br>ZYTIGA - Abiraterone Combined Chemotherapy (high dose) ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated Usual Approach Group (high dose) | Drug: Abiraterone - Usual<br>* Oral Abiraterone Combined Chemotherapy (high dose)<br>* Other names: ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral;|
| Experimental: Abiraterone - Study<br>ZYTIGA - Abiraterone Combined Chemotherapy (low dose) ZYTIGA - abiraterone acetate tablet ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated Usual Approach Group (low dose) | Drug: Abiraterone - Study<br>* Oral Abiraterone Combined Chemotherapy (low dose)<br>* Other names: ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated for Oral;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. | Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy High Dose on ZYTIGA - Abiraterone plus RAYOS - Prednisone plus ORGOVYX - Relugolix to be the usual approach group. Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy Low Dose on ZYTIGA - Abiraterone plus RAYOS - Prednisone plus ORGOVYX - Relugolix 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. | Up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PC, Prostate Cancer, SNP, Oncology, Genetics, Pharmacogenomics, CYP