Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

May 31, 2016

Study Completion Date

June 30, 2016

Conditions
Prostate Cancer MetastaticHormone Refractory Prostate CancerCastration-resistant 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

abiraterone acetate

Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.

Trial Locations (21)

10016

NYU Clinical Cancer Center, NYU Langone Medical Center, New York

10029

The Mount Sinai Medical Center, New York

13210

Associated Medical Professionals of New York, PLLC, Syracuse

13421

Associated Medical Professionals of NY, PLLC, Oneida

20007

Georgetown University Medical Center - Lombardi Cancer Center, Washington D.C.

20770

Mid Atlantic Urology Associates, Mid Atlantic Clinical Research, Greenbelt

23462

Urology of Virginia, Virginia Beach

29572

Carolina Urologic Research Center, Myrtle Beach

37209

Urology Associates, P.C., Nashville

46202

Indiana University, Indianapolis

68130

GU Research Center, LLC, Omaha

80211

The Urology Center of Colorado, Denver

91942

Cancer Center Oncology Medical Group, La Mesa

92037

UCSD Medical Center - La Jolla, La Jolla

92093

Moores UCSD Cancer Center, La Jolla

92103

UCSD Medical Center - Hillcrest, San Diego

92123

Medical Oncology Associates - SD, San Diego

Sharp Rees-Stealy, San Diego

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

97213

Providence Cancer Center Oncology and Hematology Care, Portland

98101

Virginia Mason Medical Center, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Dendreon

INDUSTRY

NCT01487863 - Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter