Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

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

Detailed Description
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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.

Official Title
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An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: sipuleucel-T


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sipuleucel-T<br>Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions. | Biological: sipuleucel-T<br>* Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)<br>* Other names: • Provenge® • APC8015;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgen independent prostate cancer (AIPC), CRPC, prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine, prostate specific antigen (PSA), prostatic adenocarcinoma