Apalutamide + Hormone Therapy for Prostate Cancer

Recruiting at284 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Aragon Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests whether combining apalutamide with another treatment helps men with high-risk prostate cancer undergoing radiation therapy. The treatment aims to block and reduce male hormones that fuel cancer growth, potentially preventing the cancer from spreading. Apalutamide has been developed for treating prostate cancer and has shown effectiveness.

Research Team

Aragon Pharmaceuticals, Inc. Clinical Trial

Principal Investigator

Aragon Pharmaceuticals, Inc.

Eligibility Criteria

Men over 18 with high-risk, localized or locally advanced prostate cancer who are set to receive primary radiation therapy. They must be in good health with a low Charlson index (<=3), able to swallow pills, and have normal liver function and adequate blood counts. Participants should not have had prior treatments for prostate cancer, no history of seizures or conditions that may cause them, and agree to use condoms.

Inclusion Criteria

Charlson index (CCI) <=3

Signed, written, informed consent

I am fully active or can carry out light work.

Exclusion Criteria

I have had both testicles surgically removed.

I have been treated with hormone therapy for prostate cancer for more than 3 months.

I have had treatment for prostate cancer, such as chemotherapy or surgery.

Treatment Details

Interventions

• Apalutamide (Androgen Receptor Inhibitor)
• Apalutamide Placebo (Androgen Receptor Inhibitor)
• Bicalutamide (Antiandrogen)
• Bicalutamide Placebo (Antiandrogen)
• GnRH (agonist) (GnRH Agonist)
• Primary Radiation Therapy (Radiation)

Trial Overview The trial is testing if adding apalutamide plus GnRH agonist to the standard radiation treatment improves survival without metastasis in men with high-risk prostate cancer. It compares this combination against placebo versions while all participants receive radiation therapy.

Participant Groups

Group I: Apalutamide Experimental Treatment 4 Interventions

Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Group II: Control group Active Control 4 Interventions

Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Who Is Running the Clinical Trial?

Aragon Pharmaceuticals, Inc.

Lead Sponsor

Trials

17

Recruited

5,400+