A Phase 2/3 interventional study of Abiraterone - Usual and Abiraterone - Study in Prostate Cancer, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. Active, not recruiting at 1 site in United States. Open to male participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Phase 2/3, Interventional, and Health services research
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 600 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* ZYTIGA - Abiraterone * Combined Chemotherapy * ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group
Drug: Abiraterone - Usual
* China Import - Abiraterone * Combined Chemotherapy * China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group
Drug: Abiraterone - Study
* Oral * Abiraterone Combined Chemotherapy
Also known as: ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral
* Oral * Abiraterone Combined Chemotherapy
Also known as: China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet for Oral
Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
* Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on ZYTIGA - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the usual approach group. * Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on China Import - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the study approach group. * Measure above every PC patient specific Abiraterone drug target (CYP17) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every PC patient specific CYP17 SNP genotype in whole genome DNA sequence. * Measure above every PC patient specific Abiraterone drug target (SULT2A1) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every PC patient specific SULT2A1 SNP genotype in whole genome DNA sequence.
Time frame: Up to 12 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair