Sipuleucel-T in Metastatic Castrate Resistant 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: 8.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic castrate resistant prostate cancer; prostate cancer; prostate; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; prostatic adenocarcinoma; Sipuleucel-T; castration resistant prostate cancer (CRPC); booster; retreatment; immune memory; immune response

Summary:

      Multicenter open label, uncontrolled study that enrolled men with metastatic castrate
      resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent
      setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up
      (LTFU) Phases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one
             infusion of sipuleucel-T

          -  Radiologic evidence of metastasis

          -  Castrate resistant prostate cancer. Subjects must have current or historical evidence
             of disease progression concomitant with surgical or medical castration, as
             demonstrated by PSA progression OR progression of measurable disease OR progression of
             non-measurable disease

          -  Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical
             castration

          -  Adequate hematologic function

        Exclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status > 2

          -  Treatment with chemotherapy within 3 months prior to registration

          -  Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation
             therapy, or any investigational product for prostate cancer within 28 days prior to
             registration

          -  Treatment with commercial sipuleucel-T (Provenge®)

          -  Current or imminent pathologic long-bone fracture or spinal cord compression

          -  Known malignancies other than prostate cancer likely to require treatment within 6
             months following 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 GM-CSF

          -  Any infection requiring antibiotic therapy or causing fever within 1 week prior to
             registration

          -  Any surgery requiring general anesthetic within 28 days prior to registration