Apalutamide + Abiraterone Acetate + Prednisone for Prostate Cancer

Recruiting at184 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Aragon Pharmaceuticals, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests apalutamide added to a standard treatment for advanced prostate cancer. It targets patients whose cancer has spread and who haven't had chemotherapy. The treatment works by blocking and lowering male hormones that help cancer grow. Apalutamide has shown efficacy in treating different stages of prostate cancer.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Men with advanced prostate cancer that hasn't spread to the brain and haven't had chemotherapy. They must have a specific type of tumor (adenocarcinoma), evidence of metastasis, and show cancer progression despite hormone therapy. Prior use of certain anti-androgens is allowed if followed by disease progression.

Inclusion Criteria

My prostate cancer has worsened, shown by rising PSA levels or changes in scans.

I have been diagnosed with prostate adenocarcinoma.

I stopped taking my first-generation anti-androgen medication over 6 weeks ago and my prostate cancer is still getting worse.

Exclusion Criteria

I stopped taking medications that can cause seizures and supplements that lower PSA levels 4 weeks ago.

My prostate cancer is of a specific type: small cell or neuroendocrine.

I have had chemotherapy for prostate cancer only as part of initial treatment.

Treatment Details

Interventions

• Abiraterone acetate (Androgen Synthesis Inhibitor)
• Apalutamide (Androgen Receptor Inhibitor)
• Prednisone (Corticosteroid)

Trial Overview The trial tests if adding Apalutamide to standard treatment with Abiraterone Acetate and Prednisone improves outcomes in men with metastatic castration-resistant prostate cancer who haven’t received chemotherapy compared to the standard treatment alone.

Participant Groups

Group I: Group 1: AAP and apalutamide Experimental Treatment 3 Interventions

Participants will receive apalutamide 240 milligram (mg) (4\*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).

Group II: Group 2: AAP and Placebo Placebo Group 3 Interventions

Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).

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

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer

Approved in Japan as Zytiga for:

• Metastatic castration-resistant prostate cancer

Who Is Running the Clinical Trial?

Aragon Pharmaceuticals, Inc.

Lead Sponsor

Trials

17

Recruited

5,400+