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Androgen Receptor Inhibitor

Combination Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Ana Aparicio

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

New or increasing non-bone disease (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)

Surgically or ongoing medically castrated, with baseline testosterone levels of =< 50 ng/dL (=< 2.0 nM)

Must not have

Known active or symptomatic viral hepatitis or chronic liver disease

Active infection (requiring oral or IV antibiotics or antiviral therapy) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated; known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing abiraterone acetate, prednisone, and apalutamide with or without ipilimumab or cabazitaxel and carboplatin to treat patients with castration-resistant prostate cancer.

Who is the study for?

Men with advanced prostate cancer that is resistant to castration and has spread, who can provide consent, have adequate organ function (blood counts, liver enzymes), and are not on certain medications. They must have a low testosterone level due to surgery or ongoing treatment, be able to swallow pills, agree to use contraception if necessary, and allow tissue collection for studies.

What is being tested?

The trial tests how well abiraterone acetate, prednisone, and apalutamide work together compared with the addition of ipilimumab or cabazitaxel plus carboplatin. It aims to see which combination is more effective in stopping tumor growth by reducing androgens or killing tumor cells directly.

What are the potential side effects?

Possible side effects include immune system reactions from monoclonal antibodies like ipilimumab; chemotherapy-related issues such as nausea; fatigue; blood cell count changes from drugs like cabazitaxel and carboplatin; hormonal changes due to abiraterone acetate and apalutamide.

Eligibility Criteria

Inclusion Criteria

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

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My cancer outside of bones is growing or new.

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I am undergoing treatment to lower my testosterone levels below 50 ng/dL.

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I can take care of myself but might not be able to do heavy physical work.

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My kidneys are functioning well enough (creatinine clearance >= 40 mL/min).

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My prostate cancer was confirmed by a lab test.

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My bone scan shows 2 or more new lesions due to prostate cancer.

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I can swallow pills without any difficulty.

Exclusion Criteria

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

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

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I do not have an active infection or a condition that prevents steroid use, and I do not have HIV/AIDS.

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I have had serious heart issues or a heart attack in the last 6 months.

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I have untreated spinal cord compression that causes symptoms.

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I have a history of conditions that could cause my bowel to tear.

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I have previously been treated with ipilimumab.

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I haven't had cancer treatments in the past 5 years, except for non-serious skin or bladder cancer.

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I have a digestive condition that affects how my body absorbs food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Allocation serum marker decline

Androgen receptor (AR) response marker signature

Incidence of adverse events as measured by the method of Thall et al

+1 more

Secondary study objectives

Time to treatment failure (TTF)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2B (abiraterone acetate, prednisone, ARN-509, ipilimumab)Experimental Treatment5 Interventions

Patients receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Patients also receive ipilimumab IV over 90 minutes on day 1 of courses 4-7. Courses repeat every 3 weeks in the absence of disease progression or unexpected toxicity.

Group II: Arm 2A (abiraterone acetate, prednisone, apalutamide)Experimental Treatment4 Interventions

Patients receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily in the absence of disease progression or unexpected toxicity.

Group III: Arm 3(abiraterone, prednisone, ARN509,cabazitaxel,carboplatin)Active Control6 Interventions

Patients receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Patients also receive cabazitaxel IV over 60 minutes and carboplatin IV, over 60 minutes on day 1 of courses 4-13. Courses repeat every 3 weeks in the absence of disease progression or unexpected toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone Acetate

2015

Completed Phase 4

~1880

Apalutamide

2015

Completed Phase 2

~5710