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

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

December 18, 2012

Primary Completion Date

September 28, 2020

Study Completion Date

September 28, 2020

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.

Trial Locations (16)

10065

Memorial Sloan Kettering Cancer Center, New York

10591

Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow

10604

Memorial Sloan Kettering West Harrison, Harrison

11725

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

27514

University of North Carolina, Chapel Hill

27701

Duke University Medical Center, Durham

48201

Karmanos Cancer Institute, Wayne State University, Detroit

60611

Northwestern University, Feinberg School of Medicine, Chicago

68130

Urology Cancer Center and GU Research Network, Omaha

97239

Oregon Health & Science University Knight Cancer Institute, Portland

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

NorthShore University Health System, Long Island City

Weill Cornell Medical Center, New York

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre

08903

Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

collaborator

OHSU Knight Cancer Institute

OTHER

collaborator

Rutgers Cancer Institute of New Jersey

OTHER

collaborator

Endeavor Health

OTHER

collaborator

Duke University

OTHER

collaborator

Northwestern University Feinberg School of Medicine

OTHER

collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

collaborator

University of North Carolina

OTHER

collaborator

Wayne State University

OTHER

collaborator

Perlmutter New York University Cancer Center

OTHER

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Ferring Pharmaceuticals

INDUSTRY

collaborator

GU Research Network, LLC

OTHER

collaborator

University of California, Los Angeles

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER