Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: sipuleucel-T
Intervention description: 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)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

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

Eligibility criteria:

        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