NCT03348670Active, not recruitingPhase 2/3
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 · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 15 Nov 2017
- Start date
- 18 Aug 2023
- Primary completion date
- 18 Nov 2026
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Diseases
- Prostate cancer
- NCT number
- NCT03348670
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 600
- From 18 Aug 2023 to the primary completion date, 18 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with other anti-cancer therapies and the therapies cannot be stopped currently
- Serious Risks or Serious Adverse Events of the drug product label
- The prohibition of drug products
Other illness
- 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
Other
- Serious Bleed Tendency
- Serious Risks or Serious Adverse Events of NCI Table of Side Effects
- Have no therapeutic effects
- Follow up to the most current label and plan for safety monitoring
Who the study is looking for
- 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
Criteria the registry did not label
- 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.
Age in the registry: 22 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.