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Vaccine
Abiraterone for Prostate Cancer (Drugs-SNPs Trial)
Phase 2 & 3
Waitlist Available
Led By HAN XU, M.D., Ph.D.
Research Sponsored by Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior therapy without orchiectomy
Prior therapy without prostate resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Drugs-SNPs Trial Summary
This trial is testing a treatment that could potentially help people with COVID-19 by activating the body's own ability to fight the virus.
Who is the study for?
Men with prostate cancer that's still within the prostate, who haven't had orchiectomy or prostate resection, and have stopped any previous different chemotherapy can join. They must not be on other anti-cancer therapies, have serious illnesses, multiple cancers, severe drug allergies or bleeding tendencies. Participants need to sign a consent form and agree to blood draws.Check my eligibility
What is being tested?
The trial is testing if genetic differences (SNPs) affect how well Abiraterone works for treating prostate cancer. It compares usual treatment with a study approach in two groups of 300 men each using blind random assignment. Both groups receive combined chemotherapy including Abiraterone.See study design
What are the potential side effects?
Possible side effects include those listed on the drug labels and NCI's table such as allergic reactions, bleeding issues, and other risks associated with Abiraterone which may involve liver problems, high blood pressure, fluid retention among others.
Drugs-SNPs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had treatments for my condition without having my testicles surgically removed.
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I have had prostate cancer treatment without surgery to remove the prostate.
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I have stopped any previous chemotherapy treatments.
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I am willing to have my blood drawn for tests.
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I have been diagnosed with prostate cancer.
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My cancer is only in the prostate.
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I do not have any other type of cancer.
Drugs-SNPs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
Drugs-SNPs Trial Design
2Treatment groups
Experimental Treatment
Group I: Abiraterone - UsualExperimental Treatment1 Intervention
ZYTIGA - Abiraterone
Combined Chemotherapy (high dose)
ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated
Usual Approach Group (high dose)
Group II: Abiraterone - StudyExperimental Treatment1 Intervention
ZYTIGA - Abiraterone
Combined Chemotherapy (low dose)
ZYTIGA - abiraterone acetate tablet
ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated
Usual Approach Group (low dose)
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Who is running the clinical trial?
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB ChairLead Sponsor
3 Previous Clinical Trials
640 Total Patients Enrolled
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairLead Sponsor
5 Previous Clinical Trials
1,840 Total Patients Enrolled
HAN XU, M.D., Ph.D.Principal InvestigatorMIDINC Clinical Research Multiple Group Unit
3 Previous Clinical Trials
640 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments for my condition without having my testicles surgically removed.I have had prostate cancer treatment without surgery to remove the prostate.I have stopped any previous chemotherapy treatments.I am willing to have my blood drawn for tests.I have more than one type of cancer.I have a condition that causes serious bleeding.I am aware of the serious risks or side effects of the drug.You have other serious ongoing health issues or infectious diseases.You have experienced severe side effects listed in the NCI Table of Side Effects.The treatment does not work for you.I have been diagnosed with prostate cancer.My cancer is only in the prostate.I do not have any other type of cancer.You have a severe allergy to certain medications.I agree to follow the latest safety monitoring plan.
Research Study Groups:
This trial has the following groups:- Group 1: Abiraterone - Usual
- Group 2: Abiraterone - Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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