ARN-509 +/− Abiraterone for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen bySaum Ghodoussipour, MD

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in treating patients with prostate cancer.

Eligibility Criteria

Men with high-risk prostate cancer who are planning to undergo surgery can join. They must have a Gleason score >8 or PSA >20, be in good physical condition (ECOG PS 0 or 1), and have no metastatic cancer or severe heart conditions. Their blood counts and organ functions need to meet specific levels, they should not be on seizure threshold-lowering meds for at least 4 weeks before the trial, and agree to use effective contraception.

Inclusion Criteria

Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry

Patients with Eastern Cooperative Oncology Group performance scale (ECOG PS) 0 or 1

Clinical stage T3 or less as demonstrated by abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) will be selected as the prostate is resectable

+9 more

Exclusion Criteria

Clinically significant ventricular arrhythmias within 6 months prior to randomization

Metastatic prostate cancer

Baseline moderate or severe hepatic impairment (Child-Pugh class B or C)

+5 more

Participant Groups

The trial is testing if ARN-509 works better alone or with abiraterone acetate, GnRH agonist, and prednisone in treating prostate cancer before surgery. The goal is to see if these treatments can reduce the amount of androgen since it helps prostate cancer cells grow.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (androgen receptor ARN-509, radical prostatectomy)Experimental Treatment4 Interventions

Patients receive androgen receptor antagonist ARN-509 PO daily for 3 months. Patients then undergo radical prostatectomy.

Group II: Arm II (ARN-509, abiraterone acetate, GnRH, prednisone, RP)Active Control7 Interventions

Patients receive GnRH agonist SC on day 1, androgen receptor antagonist ARN-509 PO daily PO for 4 times, abiraterone acetate PO daily for 4 times, and prednisone PO daily for 3 months. Patients then undergo radical prostatectomy.

Group III: Arm III (radical prostatectomy)Active Control3 Interventions

Patients undergo radical prostatectomy.

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

🇺🇸 Approved in United States as Zytiga for: