Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

Phase 2

Completed

Brief Summary: This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Detailed Description: Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Recruitment & Eligibility

Inclusion Criteria

Histologically documented adenocarcinoma of the prostate
Metastatic disease
Castrate resistant prostate cancer
Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
Life expectancy of ≥ 3 months
Men ≥ 18 years of age
Adequate hematologic, renal and liver function

Exclusion Criteria

Presence of known lung, liver, or brain metastases
Evidence of neuroendocrine or small cell features
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Known malignancies other than prostate cancer that are likely to require treatment within six months of registration
A requirement for systemic immunosuppressive therapy for any reason
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or granulocyte-macrophage colony-stimulating factor
Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5F or > 38.1C) within 1 week prior to registration
Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives

Treatment with any of the following medications or interventions within 28 days of registration:

Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide)
External beam radiation therapy or major surgery requiring general anesthetic
Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary
Chemotherapy
Treatment with any other investigational product

Arm && Interventions

Group	Intervention	Description
Sipuleucel-T	sipuleucel-T	Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)	Day 0 (first infusion) and up to 3 infusions at 2-week intervals

Secondary Outcome Measures

Name	Time	Method

Locations (18): Myron I. Murdock MD LLC
🇺🇸
Greenbelt, Maryland, United States
Georgetown University Medical Center
🇺🇸
Washington, D.C., District of Columbia, United States
Hematology Oncology Consultants
🇺🇸
Greenbelt, Maryland, United States
Aurora Advanced Healthcare, Inc
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Wauwatosa, Wisconsin, United States
Urology of Virginia, PLLC
🇺🇸
Virginia Beach, Virginia, United States
Texas Oncology, PA - Sammons Cancer Center
🇺🇸
Dallas, Texas, United States
Indiana University Department of Urology
🇺🇸
Indianapolis, Indiana, United States
The University of Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Oncology Hematology Care, Inc.
🇺🇸
Cincinnati, Ohio, United States
Oncology Specialists, S.C.
🇺🇸
Park Ridge, Illinois, United States
NYU Cancer Institute
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New York, New York, United States
Mount Sinai School of Medicine Department of Urology
🇺🇸
New York, New York, United States
Maine Center for Cancer Medicine
🇺🇸
Scarborough, Maine, United States
John Theurer Cancer Center at Hackensack
🇺🇸
Hackensack, New Jersey, United States
Virginia Mason Medical Center Urology and Renal Transplantation
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Seattle, Washington, United States
GU Oncology Research Program
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Durham, North Carolina, United States
Sarah Cannon Research Institute
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Nashville, Tennessee, United States
Columbia University Medical Center
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New York, New York, United States