L-BLP25 (Stimuvax) in Prostate Cancer

• Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T cells at 2 Months After Radiation. [ Time Frame: Baseline (Day -16 to -1) to Week 27 (approximately 2 months after radiation) ] [ Designated as safety issue: No ]
  To determine impact of L-BLP25 vaccine in addition to standard treatment on the MUC1 specific systemic immune response in patients with newly diagnosed high risk prostate cancer L-BLP25 vaccine in combination with Androgen Deprivation Therapy (ADT) and radiation therapy.
• Change from Baseline in the Enzyme-linked Immunosorbent Spot (ELISPOT) Level of Mucin-1 specific T cells at 6 Months After Radiation. [ Time Frame: Baseline (Day -16 to -1) to Week 40 (approximately 6 months after radiation) ] [ Designated as safety issue: No ]
  To determine impact of L-BLP25 vaccine in addition to standard treatment on the MUC1 specific systemic immune response in patients with newly diagnosed high risk prostate cancer L-BLP25 vaccine in combination with Androgen Deprivation Therapy (ADT) and radiation therapy.

• Kaplan-Meier Estimates of Time to Disease Recurrence based on Prostate-specific antigen (PSA) Levels [ Time Frame: up to month 24 ] [ Designated as safety issue: No ]
  To evaluate progression/recurrence status up to 24 months after randomization in patients receiving L-BLP25 vaccine in combination with the standard treatment versus patients receiving standard treatment alone.
• Percentage of Participants with a Doubling in Number of T-cells in tumor biopsy from Baseline to Week 27 [ Time Frame: Baseline (Day -16 to -1) to Week 27 ] [ Designated as safety issue: No ]
  To analyze immunologic responses (in the tumor microenvironment) in patients consenting to undergo study biopsies.
• Percentage of Participants with a Doubling of Number of T-cells in tumor biopsy from Baseline to Week 40 [ Time Frame: Baseline (Day -16 to -1) to Week 40 ] [ Designated as safety issue: No ]
  To analyze immunologic responses (in the tumor microenvironment) in patients consenting to undergo study biopsies.

This study examines Stimuvax (L-BLP25) in combination with standard treatment for prostate cancer.

• Drug: Radiation
  Radiation therapy
• Drug: Androgen Deprivation Therapy (ADT)
  ADT
• Other: Standard of care
  Standard of Care
• Drug: L-BLP25
  L-BLP25 with single dose of cyclophosphamide 3 days before the first vaccine

• Active Comparator: Standard therapy
  Radiation therapy in combination with androgen deprivation therapy (ADT).
  Interventions:

  • Drug: Radiation
  • Drug: Androgen Deprivation Therapy (ADT)
• Experimental: Standard therapy plus L-BLP25
  Radiation therapy in combination with androgen deprivation therapy plus L-BLP25 vaccine
  Interventions:

  • Other: Standard of care
  • Drug: L-BLP25

Inclusion Criteria:

• Must have newly diagnosed prostate cancer with high risk features
• No evidence of metastatic disease on CT or bone scans
• No systemic steroid use within 2 weeks prior to initiation of experimental therapy
• ECOG performance status of 0-1, HLA-A2 or A3 positive for immunologic monitoring, baseline renal function, hepatic function

Exclusion Criteria:

• No evidence of being immunocompromised by human immunodeficiency virus
• A medical condition requiring systemic steroids
• A medical condition requiring immunosuppressive therapy
• Splenectomy
• Active Hepatitis B or Hepatitis C
• A clinically significant cardiac disease
• Patients who have received any prior therapy for prostate cancer
• Patients who have known brain metastasis
• Patients receiving any other investigational agents
• Contraindication to biopsy
• Bleeding disorders
• Artificial heart valve
• Patients weighing >136 kilograms
• Allergy to MR contrast agent
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices
• Pre-existing and active prostatitis or proctitis
• Inflammatory bowel disease or known genetic sensitivity to ionizing radiation
• History of prior radiation to the pelvis