Study of Trovax® Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer

Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer.

Trovax is vaccine that targets 5T4 receptors on tumor cells. 5T4 has been detected in the
majority of primary prostate cancers. Based on pre-clinical and clinical data, it may be
advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses,
thus leading to a more therapeutic approach for patients with metastatic androgen
independent prostate cancer (AIPC).

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate.

- Progressive disease after androgen deprivation.

- ECOG Status < 2.

- No prior chemotherapy for prostate cancer therapy

- At least four weeks have lapsed since prior chemotherapy (if administered)

- Patients on stable doses of bisphosphonates that show subsequent tumor progression
may continue on this medication; however, patients are not allowed to initiate
bisphosphonate therapy within one month prior to starting therapy or throughout the
study.

- Clinically immunocompetent.

- Free of clinically apparent/active autoimmune disease

- Absolute Lymphocyte Count ≥ 500/µl, ANC >1200/µl, Platelet count >100,000/µl,
Hemoglobin > 10 mg/dl, Peripheral neuropathy <1.

- No evidence of active ischemia on ECG

- Age greater 18 years

Exclusion Criteria:

- Patients who have received prior chemotherapy.

- Patients receiving any other hormonal therapy, including any dose of megestrolacetate
(Megace), Proscar (finasteride), any herbal product known to decrease PSA levels
(e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the
agent for at least 4 weeks prior to enrollment. Progressive disease (as defined
above) must be documented after discontinuation of the hormonal therapy.

- Patients that initiate bisphosphonate therapy within one month prior to starting
therapy or throughout the study.

- No supplements or complementary medicines/botanicals are permitted during the study,
except for any combination of the following: conventional multivitamin supplements,
selenium, lycopene, soy supplements, Vitamin E

- Patients should review the label with their doctor prior to enrollment, and
discontinue disallowed agents prior to study enrollment

- Major surgery or radiation therapy completed < 4 weeks prior to enrollment.

- Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

- "Currently active" second malignancy, other than non-melanoma skin cancer. Patients
are not considered to have a "currently active" malignancy if they have completed
therapy more than 5 years previously and have no known evidence of residual or
recurrent disease

- Serious intercurrent infections or nonmalignant medical illnesses which are
uncontrolled.

- Psychiatric illnesses/social situations that would limit compliance with protocol
requirements.

- AST and ALT and Alkaline Phosphatase must be within the range allowing for
eligibility. In determining eligibility the more abnormal of the two values (AST or
ALT) should be used. The bilirubin must be within normal limits.

- Renal function creatinine ≥1.5 x ULN.

- Known allergy to egg proteins.

- Known allergy to neomycin.

- History of allergic response to previous vaccinia vaccinations.

- Chronic oral corticosteroid use (especially anti-emetics) unless prescribed as
replacement therapy in the case of adrenal insufficiency.

- Known to test positive for HIV or hepatitis B or C - testing prior to study not
required.

- Clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%.

- Requirement for radiotherapy (this is a sign of disease progression and is classed as
a withdrawal criterion).

- Concurrent chemotherapy, immunotherapy and radiation therapy

- No investigational or commercial agents or therapies other than those included in
protocol treatment may be administered with the intent to treat the patient's
malignancy.

- Prior exposure to TroVax®.