What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as Abiraterone Acetate (CYP17 Inhibition), Enzalutamide, and chemotherapy agents like Docetaxel and Cabazitaxel, have various side effects. Abiraterone and Enzalutamide can increase the occurrence of fatigue and other adverse events. Docetaxel combined with androgen deprivation therapy (ADT) significantly increases the risk of severe myelosuppression and other grade 3 to 5 adverse events. Cabazitaxel, while offering some clinical benefits, is associated with a higher incidence of neutropenia, diarrhea, infection, and fatigue. Overall, these treatments can lead to a range of side effects, from mild to severe, impacting the patient's quality of life.

What prior FDA approvals exist?

Abiraterone acetate, a CYP17 inhibitor, has been FDA-approved for the treatment of metastatic castration-resistant prostate cancer (CRPC) and has demonstrated significant survival benefits. Similar treatments include enzalutamide, an androgen receptor signaling inhibitor, and docetaxel, a taxane-based chemotherapy. These drugs are frequently used in combination with androgen deprivation therapy (ADT) to enhance treatment efficacy in advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to Abiraterone Acetate for prostate cancer patients include: 1) Enzalutamide, which has shown improved survival in metastatic hormone-sensitive prostate cancer. 2) Apalutamide, effective in both metastatic castration-sensitive and castration-resistant prostate cancer. 3) Olaparib, particularly for patients with homologous recombination repair (HRR) gene mutations, as it has shown significant prolongation in progression-free survival. 4) Lutetium-177-PSMA-617, a radioligand therapy that has demonstrated efficacy in metastatic castration-resistant prostate cancer.

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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

Must not have

Have more than one different kind of cancer at the same time

Serious Bleed Tendency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a combination of three drugs to treat prostate cancer. It targets men with prostate cancer to see how their genes affect treatment results. The drugs work by lowering hormones, reducing inflammation, and controlling hormone levels.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have more than one type of cancer.

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I have a condition that causes serious bleeding.

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I am aware of the serious risks or side effects of the drug.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments primarily target androgen signaling, which is crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces testosterone levels, slowing cancer progression. Second-generation androgen receptor inhibitors, such as enzalutamide and apalutamide, block androgen receptors, preventing cancer cells from using androgens. Abiraterone acetate, a CYP17 inhibitor, blocks the production of androgens not only in the testes but also in the adrenal glands and the tumor itself. This comprehensive inhibition of androgen production is particularly important for patients with advanced or metastatic prostate cancer, as it can significantly prolong survival and delay disease progression.