Combination Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Ana Aparicio | MD Anderson Cancer Center

Overseen byAna Aparicio

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies the side effects and how well abiraterone acetate, prednisone, and apalutamide work with or without ipilimumab or cabazitaxel and carboplatin in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as abiraterone acetate and apalutamide may lessen the amount of androgens made by the body. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as prednisone, cabazitaxel, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving abiraterone acetate, prednisone, and apalutamide with or without ipilimumab or cabazitaxel and carboplatin may be a better way to treat patients with castration-resistant prostate cancer that has spread to other places in the body.

Eligibility Criteria

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.

Inclusion Criteria

Presence of metastatic disease documented on imaging studies (bone scan, computed tomography [CT] and/or magnetic resonance imaging [MRI] scans)

My cancer outside of bones is growing or new.

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

+19 more

Exclusion Criteria

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

I haven't taken specific prostate cancer drugs or chemotherapy in the last year.

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

+19 more

Participant Groups

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.

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.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Zytiga for: