Discovery Stage IND EXEMPT Clinical Study About ABIRATERONE ACETATE and Single Nucleotide Polymorphisms

• Status: Active, not recruiting
• Trial end date: 2022-08-28
• Target enrollment: 0
• Participant gender: Male

Summary

That current oncology drugs on USA market have the universal problems about low effectiveness of pharmacology to cancer cells and high risk of toxicology to normal cells can demonstrate following most significantly and most reasonably: it is not enough so far away that just only oncology drug target molecules as cancer patient-specific biomarkers directly; it must be that oncology drug targets' SNPs like as real personalized or individualized cancer patient-specific biomarkers.

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

Details

• Lead Sponsor: Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair; Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
• Collaborator: PPD
• Treatments: Abiraterone Acetate; Leuprolide; Nilutamide; Prednisone; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• Clinical diagnosis of Metastatic High-Risk Castration-Sensitive Prostate Cancer (CSPC)

• Clinical prostate tissue biopsy diagnosis of Metastatic High-risk CSPC

• Suitable for enough biopsy tissue of Metastatic High-risk CSPC

• Random and double blind

• Measurable disease

• Adequate organ functions

• Adequate performance status

• Age 22 years old and over

• Receive blood-drawing

• Sign an informed consent form

Exclusion Criteria:

• Prostatectomy

• Treatment with other anti-cancer therapies and cannot be stopped currently

• Pregnancy

• Breast-feeding

• The patients with other serious inter-current illness or infectious diseases

• Have more than one different kind of cancer in the same time

• Allergy to drugs

• Serious Bleed Tendency

• Serious Risks or Serious Adverse Events of the drug product

• The prohibition of the drug product

• Have no therapeutic effects

• Follow up to the most current label