Vaccine Therapy in Treating Patients With Prostate Cancer Previously Treated With Surgery or Radiation Therapy

Inclusion Criteria

• Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesicle involvement, provided all visible disease was surgically removed) that have completed local therapy and have an elevated PSA after surgery or rising PSA after radiation therapy
• Histologically confirmed diagnosis of prostate cancer
• Previous treatment with definitive surgery or radiation therapy or both
• No evidence of metastatic disease on physical exam, computed tomography (CT)/magnetic resonance imaging (MRI)/chest x-ray (CXR), and bone scan within 4 weeks prior to randomization
• Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used > 12 months prior to enrollment
• No therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 12 months prior to enrollment; agents such as 5alpha-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids (replacement doses of steroids are allowed), PC-SPES, Saw Palmetto are not permitted at any time during the period that the PSA values are being collected
• Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL or > 6 nmol/L at the time of enrollment within 4 weeks prior to randomization
• No other signs of clinical recurrence or dissemination of prostate cancer as defined by normal CT-scan or MRI of the pelvis without local recurrence, and bone scan negative for metastases, and chest X-ray negative for metastases; prostascint scans will not be used to assess disease prior to study entry
• No concomitant therapy with steroids (replacement doses of steroids are allowed)
• All patients must have evidence of biochemical progression as determined by a reference PSA value followed by 1 confirmatory rising PSA value, higher than the previous value, obtained at least 2 weeks apart; all of these PSA values must be obtained at the same reference lab, and all must be done within 6 months prior to enrollment
• The most recent of the PSA values must be >= 2.0 ng/ml; this measurement must be obtained within 1 month prior to enrollment
• The PSA doubling time (PSA-DT) must be less than 12 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Absolute neutrophil count > 1,500/ul
• Platelets > 100,000/ul
• Total bilirubin 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 institutional ULN
• Creatinine 1.5 x ULN
• The effects of dendritic cell vaccines on the developing human fetus are unknown; for this reason men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation

Exclusion Criteria

• Patients must not be receiving other investigational agents or concurrent anticancer therapy
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not have active eczema, atopic dermatitis, or other exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, contact dermatitis, psoriasis, herpes or other open rashes or wounds)
• Presence of an active acute or chronic infection, including urinary tract infection, human immunodeficiency virus (HIV) or viral hepatitis HIV patients are excluded based on immunosuppression which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections; if clinically indicate HIV/viral hepatitis testing will be performed to confirm status
• Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; patients receiving replacement thyroid hormone would be eligible
• No concurrent use of systemic steroids, except for local (topical, nasal, or inhaled) steroid use (replacement doses of steroids allowed)
• Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and superficial bladder cancer or malignancy within last 3 years)