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%