Prostate CancerPhase 2/3Drugs-SNPsNCT03348670
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
A Phase 2/3 study testing Abiraterone - Usual and Abiraterone - Study in people with Prostate Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.
Trial 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 BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17… Read more about this study
- Who is it for?
- Ages 22 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone - Usual and Abiraterone - Study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2023to 28 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Rockville, Maryland, 20853
About this study
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.
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.
Read the detailed description
- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients.
- Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients.
- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
- Mutually compare the usual approach group SNPs (300 double blind random group separated prostate cancer patients) with the study approach group SNPs (300 double blind random group separated prostate cancer patients).
- Confirm the relationship between drug target gene SNPs and drug efficacy.
- Confirm the relationship between drug target gene SNPs and drug safety.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone - Usual, Abiraterone - Study
- Keywords
- Prostate Cancer, PC, SNP, Oncology, Genetics, Pharmacogenomics, CYP
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone - UsualDrug
Also called ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral
- Oral
- Abiraterone Combined Chemotherapy
Abiraterone - StudyDrug
Also called China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet for Oral
- Oral
- Abiraterone Combined Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone - Usual | Experimental | * ZYTIGA - Abiraterone
* Combined Chemotherapy
* ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet
* Usual Approach Group Receives: Drug: Abiraterone - Usual |
| Abiraterone - Study | Experimental | * China Import - Abiraterone
* Combined Chemotherapy
* China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet
* Usual Approach Group Receives: Drug: Abiraterone - Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start18 Aug 2023
- Primary completion18 Nov 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * The usual approach group * The study approach group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc
- Investigators
- HAN XU, MD/PhD/FAPCR, Study chair, Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701HAN XU, MD/PhD/FAPCR, Study director, Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701HAN XU, MD/PhD/FAPCR, Principal investigator, Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348670
- Sponsor's protocol ID
- IND 178620 Commercial
- Other IDs
- FWA00015357, IRB00009424, IORG0007849, NPI - 1831468511, NPI - 1023387701, IND 178620
- Acronym
- Drugs-SNPs
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2017
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.
- ClinicalTrials.gov ID
- NCT03348670
- Acronym / sponsor ID
- Drugs-SNPs / IND 178620 Commercial
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, PC, SNP, Oncology, Genetics, Pharmacogenomics, CYP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients.
- Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients.
- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
- Mutually compare the usual approach group SNPs (300 double blind random group separated prostate cancer patients) with the study approach group SNPs (300 double blind random group separated prostate cancer patients).
- Confirm the relationship between drug target gene SNPs and drug efficacy.
- Confirm the relationship between drug target gene SNPs and drug safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * The usual approach group * The study approach group
| Arm | Type | Receives |
|---|---|---|
| Abiraterone - Usual | Experimental | Drug: Abiraterone - Usual* ZYTIGA - Abiraterone * Combined Chemotherapy * ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group |
| Abiraterone - Study | Experimental | Drug: Abiraterone - Study* China Import - Abiraterone * Combined Chemotherapy * China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone - UsualAlso: ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral* Oral * Abiraterone Combined Chemotherapy | Drug | Abiraterone - Usual |
| Abiraterone - StudyAlso: China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet for Oral* Oral * Abiraterone Combined Chemotherapy | Drug | Abiraterone - Study |
Primary outcome
Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Time frame: Up to 12 weeks
* 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- FWA00015357Link provided by the sponsor.
- IRB00009424Link provided by the sponsor.
- IORG0007849Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAN XU, MD/PhD/FAPCR study chair
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
HAN XU, MD/PhD/FAPCR study director
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
HAN XU, MD/PhD/FAPCR principal investigator
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Abiraterone - Usual and Abiraterone - Study in people with Prostate Cancer, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.