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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 below

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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 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

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)

0 / 5Eligibility criteria met