A Randomized Phase II Study of L-BLP25 in Combination With Standard Androgen Deprivation Therapy and Radiation Therapy for Newly Diagnosed, High Risk Prostate Cancer Patients

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