PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Condition: Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7
MeSH terms: Prostatic Neoplasms; Adenocarcinoma
Intervention: Laboratory Biomarker Analysis; Placebo Administration; Rilimogene Galvacirepvec
Intervention description: Correlative studies; Given SC; Given SC
Intervention MeSH terms: Metronidazole; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: Male
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen
      [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer
      undergoing active surveillance. Vaccines made from a person's tumor cells may help the body
      build an effective immune response to kill tumor cells that express PSA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate with
             cancer present in at least one biopsy core, either random or targeted, in the most
             recent biopsy

               -  All prior biopsies must meet the following: =< 50% of the total number of random
                  biopsy cores positive for cancer

               -  Gleason score =< (3+4)

          -  Clinical stage =< T2a by digital rectal exam (DRE)

          -  Biopsies performed at outside institutions should have Gleason score confirmed at the
             study site by a genitourinary (GU) pathologist to ensure eligibility

          -  Pre-intervention biopsy tissue (most proximal to enrollment) with sufficient tumor
             tissue to cut 5-10 unstained slides confirmed to be available upon request

          -  Screening serum PSA < 20 ng/mL; for men treated with 5-alpha-reductase inhibitors
             (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL

          -  Neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL)

          -  Stable platelet count >= 75,000/mm^3 (>= 75 k/uL)

          -  Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper
             limit of normal (ULN)

          -  Serum creatinine =< 1.5 x ULN

          -  Karnofsky >= 70%

          -  Must agree to use medically acceptable barrier and/or chemical method of contraception
             while on study and for at least one month following the last vaccine injection; should
             a participant's partner become pregnant or suspect she is pregnant while the
             participant is participating in this study, the study physician should be informed
             immediately; in the event a participant's partner becomes pregnant, the study sponsor
             may request additional information regarding the course of the pregnancy and if the
             pregnancy is carried to term, the birth of the child (i.e., the outcome of the
             pregnancy)

          -  Ability to understand and the willingness to sign a written informed consent document

          -  No planned prostate biopsies during the intervention until after the post-intervention
             biopsy

          -  Men on stable doses of 5-alpha reductase inhibitors are eligible as long as there is
             no planned dose change while on study

        Exclusion Criteria:

          -  Have had prior treatment for prostate cancer by surgery, irradiation, local ablative
             (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation
             therapy

          -  Patients who have prostate cancer with distant metastases

          -  Have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or
             radiation for any malignancies within the past 2 years

          -  Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the
             treating physician, would make this protocol unreasonably hazardous for the patient;
             such illnesses/conditions may include, but are not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic
             or unstable cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Positive for human immunodeficiency virus (HIV) or active infections for hepatitis B,
             and/or hepatitis C, based on medical history

          -  Prior solid organ or bone marrow transplant

          -  Immunodeficiency or splenectomy

          -  Chronic immunosuppressive therapy within 30 days of screening

          -  Inflammatory eye disease requiring steroid treatment within 28 days of screening

          -  Chronic administration (defined as daily or every other day for continued use > 14
             days) of systemic corticosteroids within 28 days of the first planned dose of
             PROSTVAC-V/F; use of inhaled steroids, nasal sprays, and topical creams for small body
             areas is allowed

          -  History of or active autoimmune disease including but not limited to autoimmune
             neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus,
             Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome; persons
             with vitiligo are not excluded; Persons with well-controlled autoimmune
             endocrinopathies, e.g., diabetes mellitus, Graves' disease, Hashimoto's thyroiditis,
             Addison's disease are not excluded; persons with well-controlled rheumatoid arthritis,
             psoriatic arthritis and polymyalgia rheumatica are not excluded

          -  Known allergy to eggs, egg products

          -  Prior or concurrent eczema or other eczemoid skin disorders or active skin condition
             (acute, chronic, or exfoliative) that disrupts the epidermis; persons with psoriasis
             are not excluded except in cases of:

               -  any active lesion

               -  any active lesion in the previous 6 months that required treatment, either
                  systemic or topical

               -  any prior episode, at any time, extensive enough or severe enough as to require
                  systemic treatment

          -  Previous adverse reactions to smallpox vaccination

          -  Unable 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, (d) individuals with other acute, chronic, or exfoliative skin condition,
             or (e) immunocompromised or immunosuppressed persons (by disease or therapy)

          -  Participants may not be receiving any other investigational agents

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition of PROSTVAC