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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2026-05-28

Brief Summary

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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 prednisone tablet plus BICALUTAMIDE tablet, 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 China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, 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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* The usual approach group
* The study approach group

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

No-placebo and random and double blind

Study Groups

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Abiraterone - Usual

* ZYTIGA - Abiraterone
* Combined Chemotherapy
* ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet
* Usual Approach Group

Group Type EXPERIMENTAL

Abiraterone - Usual

Intervention Type DRUG

* Oral
* Abiraterone Combined Chemotherapy

Abiraterone - Study

* China Import - Abiraterone
* Combined Chemotherapy
* China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet
* Usual Approach Group

Group Type EXPERIMENTAL

Abiraterone - Study

Intervention Type DRUG

* Oral
* Abiraterone Combined Chemotherapy

Interventions

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Abiraterone - Usual

* Oral
* Abiraterone Combined Chemotherapy

Intervention Type DRUG

Abiraterone - Study

* Oral
* Abiraterone Combined Chemotherapy

Intervention Type DRUG

Other Intervention Names

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ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet for Oral

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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HAN XU, MD/PhD/FAPCR

Role: STUDY_CHAIR

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

HAN XU, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

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

HAN XU, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Rockville, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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