Tecemotide (L-BLP25) in Prostate Cancer

Inclusion Criteria:

- Histopathologic documentation of prostate cancer confirmed at the institution of study
enrollment prior to starting this study

- Newly diagnosed or previously untreated prostate cancer with intermediate or high risk
features as defined in the protocol

- No evidence of metastatic disease on computed tomography (CT) / magnetic resonance
imaging (MRI) or bone scans

- No systemic steroid use within 2 weeks prior to initiation of experimental therapy.
Limited doses of systemic steroids to prevent intravenous contrast, allergic reaction
or anaphylaxis (in subjects who have known contrast allergies) are allowed

- Eastern Co-operative Oncology Group (ECOG) performance status of 0-1

- Human leukocyte antigen (HLA)-A2 or A3 positive for immunologic monitoring

- Hematological and biochemical eligibility parameters as defined in the protocol

- No other active malignancies within the past 3 years (with the exception of
non-melanoma skin cancers or carcinoma in situ of the bladder)

- Willing to travel to the study center(s) for follow-up visits

- Age greater than or equal to 18 years old

- Able to understand and sign informed consent

- Must agree to use effective birth control (such as a condom) or abstinence during and
for a period of 4 months after the last administration of immunotherapy

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

- Subjects should have no autoimmune diseases that have required treatment as specified
in the protocol

- History of immunodeficiency diseases, hereditary or congenital immunodeficiencies

- Serious intercurrent medical illness

- A clinically significant cardiac disease

- Subjects who have received any prior therapy for prostate cancer

- Subjects who have known brain metastasis, or with a history of seizures, encephalitis,
or multiple sclerosis

- Subjects receiving any other investigational agents

- Contraindication to biopsy such as bleeding disorders, ratio of prothrombin time to
partial thromboplastin time (PT/PTT) >=1.5 times the upper limit of normal, artificial
heart valve

- Contraindication to MRI such as subjects weighing >136 kilograms, allergy to magnetic
resonance (MR) contrast agent, subjects with pacemakers, cerebral aneurysm clips,
shrapnel injury or implantable electronic devices

- Contraindication to radiation therapy such as pre-existing and active prostatitis or
proctitis, inflammatory bowel disease or known genetic sensitivity to ionizing
radiation, or history of prior radiation to the pelvis