Abiraterone + Antiandrogen +/- Chemotherapy for Advanced Prostate Cancer

Recruiting at 671 trial locations

Overseen by Christos Kyriakopoulos

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, 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. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

Research Team

Christos Kyriakopoulos

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Men with metastatic, castration-resistant prostate cancer previously treated with docetaxel can join. They must have low testosterone levels, adequate organ function, and no active infections or recent heart issues. Participants need to be on standard hormone therapy and not taking other investigational drugs. Men who've had certain treatments like radium-223 are allowed.

Inclusion Criteria

I may have been treated with a specific hormone therapy before.

Creatinine < 2.0 mg/dL

Informed consent form signed

Exclusion Criteria

ALT or AST aminotransferase > 1.5 x ULN

I have received chemotherapy or therapy targeting the androgen receptor for prostate cancer.

My prostate cancer is not the common type but a rare form.

Treatment Details

Interventions

• Abiraterone Acetate (Hormone Therapy)
• Antiandrogen Therapy (Hormone Therapy)
• Cabazitaxel (Chemotherapy)
• Prednisone (Corticosteroid)

Trial Overview The trial is testing if adding cabazitaxel and prednisone to abiraterone acetate and antiandrogen therapy improves outcomes in patients whose prostate cancer has spread despite treatment. It's a randomized study comparing the effectiveness of these combinations after previous chemotherapy.

Participant Groups

Group I: Arm A (abiraterone acetate, prednisone, cabazitaxel) Experimental Treatment 7 Interventions

Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.

Group II: Arm B (abiraterone acetate, prednisone) Active Control 6 Interventions

Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.

Abiraterone Acetate is already approved in Canada, Japan for the following indications:

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in Japan as Zytiga for:

• Prostate cancer

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+