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Hormone Therapy

Apalutamide + Abiraterone + Prednisone for Prostate Cancer

Phase 2

Waitlist Available

Led By Bagi Jana, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of metastatic disease that can be biopsied by any methodology applicable

Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy

Must not have

History of another malignancy within the previous 2 years with > 30 % probability of relapse other than curatively treated non-melanomatous skin cancer

Gastrointestinal disorder affecting absorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well 2 drugs plus steroids work to treat prostate cancer that has spread to other parts of the body. They may stop cancer growth by blocking enzymes needed for cell growth.

Who is the study for?

Men with metastatic castration resistant prostate cancer, who have low testosterone levels and progressive disease despite ongoing hormone therapy. They must be able to give consent, swallow pills, and agree to use two forms of birth control if sexually active with a woman of childbearing potential. Excluded are those with severe health issues like uncontrolled hypertension or heart problems, recent major surgery, brain metastases, certain blood disorders or allergies to study drugs.

What is being tested?

The trial is testing the effectiveness of combining apalutamide and abiraterone acetate—drugs that block tumor growth enzymes—with prednisone which suppresses the immune system and may improve bone marrow function in treating metastatic prostate cancer that resists castration treatment.

What are the potential side effects?

Potential side effects include fatigue, digestive issues such as nausea or diarrhea, liver problems indicated by changes in blood tests results for liver function; skin rash; joint pain; high blood pressure; fluid retention leading to swelling in legs or feet; hot flushes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread and can be biopsied.

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I am currently on hormone therapy for cancer or have had an orchiectomy.

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I have had at most two chemotherapy treatments for my metastatic prostate cancer.

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I am fully active or can carry out light work.

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My cancer has worsened, shown by rising PSA levels or growth in bones or soft tissues.

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My prostate cancer is confirmed and does not have neuroendocrine or small cell features.

Exclusion Criteria

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

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I have had cancer other than skin cancer in the past 2 years with a high chance of return.

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I have a stomach or intestine condition that affects how my body absorbs food.

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My cancer has spread to my brain.

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I have not had radiation therapy in the last 3 weeks.

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I have weak bones at risk of breaking.

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I have not had a seizure, fainted, or had a mini-stroke in the last year.

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I have a serious heart condition.

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I am not taking any medications that can increase the risk of seizures.

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I have a history of serious bleeding problems not related to my cancer.

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I have active or symptomatic viral hepatitis or chronic liver disease.

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I have a known issue with my pituitary or adrenal glands.

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My liver is not working well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Androgen expression signaling

Composite progression free survival (PFSc)

Incidence of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (abiraterone acetate, apalutamide, prednisone)Experimental Treatment3 Interventions

Participants receive abiraterone acetate PO once daily QD, apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Abiraterone Acetate

2015

Completed Phase 4

~1880