A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer

Inclusion Criteria:

* Signed Informed Consent
* Men, 18 - 75 years of age
* Documented prostate cancer with a rising PSA post androgen suppression or blockade therapy
* Chemotherapy naïve
* ECOG Performance Score of 0,1, or 2
* Life expectancy ≥ 1 year
* No significant cardiac, bone marrow, hepatic, or renal dysfunction; or coagulopathy (defined as no AE ≥ Grade 3 according to NCI CTCAE v 3.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter may be eligible for inclusion provided an exemption is granted by the study Medical Monitor prior to enrollment.
* A negative virology screen for HIV, hepatitis B surface antigen, and hepatitis C

Exclusion Criteria:

* Metastatic disease
* Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
* History of prior malignancies other than prostate cancer within the past 5 years, excluding basal or squamous cell carcinoma of the skin
* Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin or tobramycin
* Chronic administration (defined as 5 or more days of consecutive use) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN®-PRO. Use of inhaled steroids, nasal sprays, eye drops and topical creams for small body areas is allowed.
* History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement hormones are not excluded.
* Prior solid organ or hematopoietic allogenic transplant(s)
* Receipt of an investigational agent within 28 days of the first planned dose of MVA-BN®-PRO
* Prior "vaccine" therapy for prostate cancer at any time
* Vaccination: Live (attenuated) vaccine (e.g., FluMist®). Vaccination with a live vaccine within 28 days of the first planned dose of MVA-BN®-PRO, or plans to receive a live vaccine within 28 days after the last dose of MVA-BN®-PRO is not allowed
* Vaccination: Killed (inactivated) vaccine (e.g., PneumoVax®). Vaccination with a killed vaccine within 14 days of the first planned dose of MVA-BN®-PRO, or plans to receive a killed vaccine within 14 days after the last dose of MVA-BN®-PRO is not allowed.
* Radiation therapy within 28 days of the first planned dose of MVA-BN®-PRO or plans for radiation therapy during treatment or re-treatment. Prior to initiating palliative radiation during the (re)treatment phase of the study, the Sponsor's medical monitor or designee must be notified.
* Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
* Study personnel