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

• Status: Active, not recruiting
• Trial end date: 2024-05-28
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair; Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair
• Treatments: Abiraterone Acetate; Etoposide; Etoposide phosphate; Everolimus; Methotrexate; Prednisone; Relugolix; Sirolimus; Topotecan

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