3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

Summary

In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). In December 2012, the FDA approved Zytiga ® in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. Degarelix (Firmagon ®), a testosterone lowering agent given as a monthly injection, is FDA approved for the treatment of patients with advanced prostate cancer. The purpose of this study is to evaluate abiraterone acetate and prednisone in combination with degarelix as a possible treatment for PSA recurrent prostate cancer as compared to abiraterone acetate alone and degarelix alone. This will be the first time these drugs will be used together.

Conditions

• Prostate Cancer

Interventions

DRUG

Abiraterone acetate

Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.

DRUG

Abiraterone acetate plus degarelix

Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.

DRUG

Degarelix

Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC

  collaborator INDUSTRY

• OHSU Knight Cancer Institute

  collaborator OTHER

• Rutgers Cancer Institute of New Jersey

  collaborator OTHER

• Endeavor Health

  collaborator OTHER

• Duke University

  collaborator OTHER

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Perlmutter New York University Cancer Center

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Ferring Pharmaceuticals

  collaborator INDUSTRY

• GU Research Network, LLC

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Howard I Scher, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-18

Primary Completion

2020-09-28

Completion

2020-09-28

Countries

• United States

Study Locations