Status:
ACTIVE_NOT_RECRUITING
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Lead Sponsor:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Conditions:
Prostate Cancer
Eligibility:
MALE
22-75 years
Phase:
PHASE2
PHASE3
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 prednisone tablet plus B...
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 precisi...
Eligibility Criteria
Inclusion
- 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 on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, 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 on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, like as the study approach group.
- 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
- 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
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 28 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03348670
Start Date
August 18 2023
End Date
May 28 2026
Last Update
August 17 2025
Active Locations (1)
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1
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Rockville, Maryland, United States, 20853