Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

This study is for adult male patients who have recently undergone radical prostatectomy and
are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F
has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational
drug.

Inclusion Criteria:

- Age >/= 21 and willing to give consent

- Completed radical prostatectomy for pathologically-verified adenocarcinoma of the
prostate no more than 120 days prior to enrollment.

- Post-operative PSA <0.2ng/mL by 120 days after prostatectomy

- Must have one or more of the following: pT3b or pT4 primary tumor; Gleason score 8-10;
pN1 lymph node disease; positive surgical margins; pre-operative PSA of > 10ng/mL
Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant
radiation, may also be enrolled.

- ECOG performance status 0-1

- Adequate hematologic, renal, liver function as outlined in the protocol.

- Subject of fathering potential must use an adequate method of contraception to avoid
conception throughout the study and for at least 4 weeks after the last dose of study
drug to minimize the risk of pregnancy.

- Subjects must have had a negative bone scan, and CT of abdomen and pelvis within 16
weeks prior to registration. Additional forms of imaging (Prostascint scan, MRI) may
be substituted for a CT scan of the abdomen and pelvis if clinically indicated.

Exclusion Criteria:

- Pure small cell carcinoma of the prostate

- Radiographically-demonstrable metastases at any time prior to the time of enrollment

- Diagnosis of cancer requiring systemic therapy in the past 5 years

- Presence of any major medical condition which, in the opinion of the investigator,
precludes participation in the study

- Neoadjuvant or adjuvant therapy of any kind

- Chronic administration (defined as daily or every other day for continued use > 14
days) of systemic glucocorticoids within 28 days of the first planned dose of
PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and all topical preparations
(creams, solutions, gels, ointments, etc.) for up to 5% of the body surface area is
allowed.

- Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids,
TNF antagonists, antibodies to IL6 or IL6R, calcineurin inhibitors, mTOR antagonists

- Prior history of serious toxicity or a systemic reaction to vaccinia immunization such
as myopericarditis progressive vaccinia infection, or eczema vaccinatum.

- Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt
epidermis

- Active infections requiring systemic therapy

- Serologic evidence of HIV/AIDS.

- Positive hepatitis C serology or active hepatitis B infection.

- History of allergy to eggs, egg products, aminoglycoside antibiotics

- History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart
failure, ischemic cardiomyopathy

- Prior solid organ or stem cell transplant

- History of or active autoimmune disease (e.g., autoimmune neutropenia,
thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogren's
syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease,
Hashimoto's thyroiditis, or Graves disease). Persons with vitiligo are not excluded.

- Uncontrolled diabetes. Subjects with diabetes mellitus are not excluded if the
condition is well-controlled (A1C < 7.5).

- Vaccination with live attenuated vaccine within 28 days prior to day 1 of PROSTVAC-V/F
administration or vaccination with a killed vaccine within 14 days prior to day 1 of
PROSTVAC-V/F.

- Inability to avoid close contact or household contact with the following high-risk
individuals for three weeks after the Day 1 vaccination or until the vaccination site
heals completely: (a) children ≤ 3 years of age; (b) pregnant or nursing women; (c)
individuals with prior or concurrent extensive eczema or other eczemoid skin
disorders; or (d) immunocompromised individuals, such as those with HIV.

- Any condition which, in the opinion of the investigator, would prevent full
participation in this trial (including Follow-Up), or would interfere with the
evaluation of the trial endpoints.