Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms (Drugs-SNPs)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Abiraterone - Usual; Drug: Abiraterone - Study

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20853
      • Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abiraterone - Usual; 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; Oral; Abiraterone Combined Chemotherapy (high dose); 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; 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; Oral; Abiraterone Combined Chemotherapy (low dose); 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

Collaborators and Investigators

• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
• Investigators: Study Chair: HAN XU, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701; Study Director: HAN XU, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701; Principal Investigator: HAN XU, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Publications and helpful links

General Publications

• Gomaa AA, Abdel-Wadood YA. The potential of glycyrrhizin and licorice extract in combating COVID-19 and associated conditions. Phytomed Plus. 2021 Aug;1(3):100043. doi: 10.1016/j.phyplu.2021.100043. Epub 2021 Feb 17.
• Buder F, Selejan SR, Hohl M, Kindermann M, Herr C, Lepper PM, Bals R, Salzberger B, Mahfoud F, Bohm M. Glycyrrhizin through liquorice intake modulates ACE2 and HMGB1 levels-A pilot study in healthy individuals with implications for COVID-19 and ARDS. PLoS One. 2022 Oct 17;17(10):e0275181. doi: 10.1371/journal.pone.0275181. eCollection 2022.
• Li J, Xu D, Wang L, Zhang M, Zhang G, Li E, He S. Glycyrrhizic Acid Inhibits SARS-CoV-2 Infection by Blocking Spike Protein-Mediated Cell Attachment. Molecules. 2021 Oct 9;26(20):6090. doi: 10.3390/molecules26206090.

Helpful Links

• FWA00015357
• IRB00009424
• IORG0007849

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): May 18, 2024
• Study Completion (Estimated): May 28, 2024

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Genetics; Prostate Cancer; Oncology; Pharmacogenomics; PC; SNP; CYP
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Androgen Antagonists; Prednisone; Abiraterone Acetate; Relugolix
• Other Study ID Numbers: IND 168800 to be IND EXEMPT; FWA00015357 (Registry Identifier: HHS, Human Protections Administrator); IORG0007849 (Registry Identifier: HHS, IORG); IRB00009424 (Registry Identifier: HHS, IRB); NPI - 1831468511 (Registry Identifier: HHS, Health Care Provider Individual); NPI - 1023387701 (Registry Identifier: HHS, Health Care Provider Organization); IND 168800 (Registry Identifier: FDA IND EXEMPT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No