Clinical trial NCT03348670: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
PC
SNP
Oncology
Genetics
Pharmacogenomics
CYP
Lead sponsor: Medicine Invention Design, Inc
Sponsor class: INDUSTRY
First posted: 2017-11-21
Enrollment: 600
Sex: MALE
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * The usual approach group (high dose)
* The study approach group (low dose)
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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:

1. Clinical diagnosis of Prostate Cancer (PC)
2. Cancer in the prostate only
3. Prior therapy without orchiectomy
4. Prior therapy without prostate resection
5. Prior different chemotherapy must-need stop
6. Have no other cancer at the same time
7. Sign an informed consent form
8. Receive blood-drawing

Exclusion Criteria:

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

Primary outcomes:
measure: Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
state: Maryland
Study officials:
affiliation: Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
name: HAN XU, MD/PhD/FAPCR
role: STUDY_CHAIR
affiliation: Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
name: HAN XU, MD/PhD/FAPCR
role: STUDY_DIRECTOR
affiliation: Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
name: HAN XU, MD/PhD/FAPCR
role: PRINCIPAL_INVESTIGATOR
References: