Rilimogene Galvacirepvec and Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine in Preventing Relapse in Patients with Prostate Cancer after Radical Prostatectomy

Inclusion Criteria

• Completed radical prostatectomy for pathologically-verified adenocarcinoma of the prostate no more than 120 days prior to start of treatment. The following procedures are acceptable: radical retropubic prostatectomy (RRP), laparoscopic radical prostatectomy (with or without robotic assistance; LAPD), radical perineal prostatectomy (RPP)
• Post-operative prostate-specific antigen (PSA) < 0.2 ng/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 >= 10 ng/mL * Presence of any tertiary Gleason 5 component on the prostatectomy pathology report
• Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Total bilirubin < 1.5 x upper limit of normal (ULN)
• Hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =< 2.5 x ULN
• Serum sodium, potassium, magnesium, phosphate, and calcium >= lower limit of normal (LLN)
• Serum creatinine =< 1.5 x ULN
• Hemoglobin >= 9 gm/dL
• Neutrophil count >= 1000/mcL
• Platelets >= 100,000/mcL
• 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 computed tomography (CT) of abdomen and pelvis within 26 weeks prior to registration; additional forms of imaging (Prostascint scan, magnetic resonance imaging [MRI]) may be substituted for a CT scan of the abdomen and pelvis if clinically indicated
• ELIGIBILITY FOR THE OPTIONAL SUB-STUDY
• Patients who are being screened for the therapeutic clinical trial will also be approached for participation into the optional sub-study evaluating sociobiological response to stress; refusal to participate in the sub-study will not impact the patient’s eligibility to participate in the therapeutic intervention * Should a patient consent to the optional sub-study, the patient may proceed with the optional baseline interventions for the optional sub-study as outlined within the protocol’s study calendar

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, tumor necrosis factor (TNF) alpha antagonists, antibodies to interleukin (IL) 6 or IL6 receptor (R), calcineurin inhibitors, mammalian target of rapamycin (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 human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (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); persons with vitiligo, Hashimoto’s thyroiditis, or Graves disease are not excluded
• 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