Clinical trial · Interventional
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone - Study | Drug | — | UNRESOLVED |
| Abiraterone - Usual | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abiraterone - Usual
- description
- * ZYTIGA - Abiraterone * Combined Chemotherapy * ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group
- interventionNames
- Drug: Abiraterone - Usual
- type
- EXPERIMENTAL
- label
- Abiraterone - Study
- description
- * China Import - Abiraterone * Combined Chemotherapy * China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group
- interventionNames
- Drug: Abiraterone - Study
Primary outcomes (1)
- measure
- Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 22 Years
- Maximum age
- 75 Years
Show eligibility criteria text
* 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. 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
References
Publications (0)
Data not yet available