A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Metastatic Prostate Cancer
Interventions
BIOLOGICAL

sipuleucel-T

Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

DRUG

enzalutamide

Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Trial Locations (19)

11733

North Shore Hematology/Oncology Associates, P.C., East Setauket

13210

Associated Medical Professionals of New York, PLLC, Syracuse

19107

Thomas Jefferson University, Philadelphia

21231

Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center, Baltimore

23462

Urology of Virginia, Virginia Beach

27607

Raleigh Hematology Oncology Associates, D.B.A. Cancer Centers of North Carolina, Raleigh

29572

Carolina Urologic Research Center, Myrtle Beach

33612

H. Lee Moffitt Cancer and Research Center, Tampa

37209

Urology Associates, PC, Nashville

44195

Cleveland Clinic - Taussig Cancer Institute, Cleveland

60160

Uro Partners/ RMD Clinical Research, Melrose Park

68130

GU Research Network, Omaha

80211

The Urology Center of Colorado, Denver

85741

Urological Associates of Southern Arizona, P.C., Tucson

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

98101

Virginia Mason Medical Center, Virginia Mason Hospital, Seattle

98405

Northwest Medical Specialties, Rainier Physicians, Tacoma

06520

Yale University School of Medicine, New Haven

46804, 46845

Fort Wayne Medical Oncology and Hematology, Lutheran Hospital, Parkview Regional Medical Center, Fort Wayne

Sponsors

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INDUSTRY