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

Recruitment & Eligibility

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%

Study & Design

Arm && Interventions

Group	Intervention	Description
Arm I (cryotherapy, sargramostim)	cryotherapy	Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
Arm I (cryotherapy, sargramostim)	sargramostim	Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
Arm II (cryotherapy, standard of care)	cryotherapy	Patients undergo cryotherapy on day 0.

Primary Outcome Measures

Name	Time	Method
Change in B cell response identified by Serametrix assay	Baseline to up to 3 months after cryotherapy	A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot	Baseline to up to 3 months after cryotherapy	A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.

Secondary Outcome Measures

Name	Time	Method
Change in PSA levels in serum samples	Up to 6 months after cryotherapy

Recruitment & Eligibility