STUDY TITLE:  DENDREON 9902B - A Randomized, Double-Blind, Placebo Controlled Phase 3 Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (Provenge^Ò, APC8015) in, Metastatic, Androgen Independent Prostatic Adenocarcinomas

• Histologically documented adenocarcinoma of the prostate  
• Metastatic disease as evidenced by soft tissue and/or bony metastases on imaging studies.
• Androgen independent prostatic adenocarcinoma. 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 as defined below:
  • PSA: two consecutive PSA values, at least 14 days apart, each = 5 ng/mL and = 50% above the minimum PSA observed during castration therapy or above the pretreatment value if there was no response.
  • Measurable disease: =50% increase in the sum of the cross products of all measurable lesions or the development of any new lesions. The change will be measured against the best response to castration therapy or against the pre-castration measurements if there was no response.
  • Non-measurable disease
    • Soft tissue disease: the appearance of one or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
    • Bone disease: appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.
• Serum PSA = 5 ng/mL
• Castration levels of testosterone (<50 ng/dL) achieved via medical or surgical castration. Subjects receiving medical castration therapy must continue such therapy throughout the blinded portion of the study.
• Life expectance of at least 6 months
• Negative serology tests for HIV 1 and 2, HTLV-1, Hepatitis B and C.

• The presence of lung, liver or known brain metastases, pleural effusions or ascites
• Use of non-steroidal antiandrogens (e.g., flutamide, nilutamide or bicalutamide) within 6 weeks of registration. Subjects who demonstrate an anti-androgen withdrawal response, defined as a = 25% drop in PSA within four weeks (flutamide) or six weeks (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen are not eligible until the PSA rises above the nadir observed after anti-androgen withdrawal.
• Treatment with chemotherapy within 6 months of registration. Additionally, subjects who received more than two chemotherapy regimens at any time prior to registration are excluded.
• Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration. Subjects taking bisphosphonate therapy within 28 days prior to registration. Subjects taking bisphosphonate medication should not have their dosing regimen altered during the blinded portion of the trial unless medically warranted.
• Treatment with any of the following medications or interventions within 28 days of registration:
  • Systemic corticosteroids. Use of inhaled, intranasal and topical steroids is acceptable.
  • External beam radiation therapy or surgery
  • PC-SPES or Saw Palmetto· Megestrol acetate (Megace) or diethyl stilbesterol (DES)
  • Ketoconazole
  • 5-a-reductase inhibitors (e.g. finasteride), high dose calcitriol [1,25(OH)2VitD] or any other systemic therapy for prostate cancer