To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 122.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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 randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with
      metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with
      different concentrations of PA2024 antigen
    

Eligibility criteria:

        Inclusion Criteria:

        For a subject to be eligible for participation in this study, all of the following criteria
        must be satisfied.

          -  Histologically documented adenocarcinoma of the prostate.

          -  Metastatic disease.

          -  Progressive androgen independent castrate resistant prostate cancer.

          -  Serum PSA ≥ 5.0 ng/mL.

          -  Life expectancy of ≥ 6 months.

          -  Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical
             castration.

          -  Men ≥ 18 years of age.

          -  Adequate hematologic, renal and liver function.

        Exclusion Criteria:

        A subject will not be eligible for participation in this study if any of the following
        criteria apply.

          -  The presence of known lung, liver, or brain metastases, malignant pleural effusions,
             or malignant ascites.

          -  A requirement for treatment with opioid analgesics for any reason within 21 days prior
             to registration.

          -  Moderate to severe disease related pain.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

          -  Use of non-steroidal antiandrogens within 6 weeks of registration.

          -  Anti-androgen withdrawal response.

          -  Treatment with chemotherapy within 3 months of registration.

          -  More than 2 chemotherapy regimens prior to registration.

          -  Initiation or discontinuation of bisphosphonate therapy within 28 days prior to
             registration.

          -  Treatment with any of the following medications or interventions within 28 days of
             registration:

               -  Systemic corticosteroids,

               -  External beam radiation therapy or surgery,

               -  Dietary and herbal supplements, as well as alternative treatments that have
                  evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC)
                  -SPES or PC-SPEC) and saw palmetto,

               -  Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate,
                  ++Ketoconazole,

               -  5-alpha-reductase inhibitors,

               -  High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day).

          -  Any other systemic therapy for prostate cancer (except for medical castration).

          -  Treatment with any investigational vaccine within 2 years of registration or treatment
             with any other investigational product within 28 days of registration.

          -  Participation in any previous study involving sipuleucel-T, regardless of whether the
             subject received sipuleucel-T (APC8015) or placebo.

          -  Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical
             erosion on radiography > 50%) or spinal cord compression.

          -  A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous
             cell skin cancers must have been adequately treated and the subject must be
             disease-free at the time of registration. Subjects with a history of stage I or II
             cancer must have been adequately treated and been disease-free for ≥ 3 years at the
             time 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 > 100.5°F
             or > 38.1°C) 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.