The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer

PRIMARY OBJECTIVES:

I. Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy treatment for prostate cancer.

II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim) response and post-cryotherapy for the prostate cancer.

Patients are randomized to 1 of 2 treatment arms.

ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.

ARM II (CONTROL): Patients undergo cryotherapy on day 0.

After completion of study treatment, patients are followed up for 6 months.

Inclusion criteria

• Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate
• Patients who are diagnosed with clinical stage T1a -T2c prostate cancer
• Gleason score sum of less than or equal to 7
• Prostate-specific antigen (PSA) < 20 ng/dl
• Patient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreement
• Patients must have a life expectancy of at least one year

Exclusion criteria

• Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeast
• Anticipated blood donation within the next 90 days
• Magnetic resonance imaging (MRI), computed tomography (CT) and bone scan evidence of metastatic prostate cancer regardless the PSA level; (the indication for which is clinically driven and at the discretion of the treating physician)
• Any history of current or within the past 48 hours of acute or chronic bacterial, fungal or viral infectious disease
• Documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood (>= 10%) in the past 6 months
• Previous organ transplant
• Immunosuppression including primary, secondary, iatrogenic and idiopathic
• Other serious diseases (hematological, hepatic, renal, respiratory, central nervous system, autoimmune or psychiatric)
• Enrollment in other studies for any disease in the past 30 days
• Diagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC) of skin
• Prior transurethral resection of the prostate with a large tissue defect (at the discretion of the investigator)
• History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
• Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment
• Patients with a Hemoglobin of less than 12%