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

Study Overview
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Brief Summary
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This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate cancer.

Detailed Description
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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.

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

Conditions
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Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention / Treatment
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* Procedure: cryotherapy
* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (cryotherapy, sargramostim)<br>Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12. | Procedure: cryotherapy<br>* Undergo cryotherapy<br>Biological: sargramostim<br>* Given subcutaneously<br>* Other names: Prokine;|
| Active Comparator: Arm II (cryotherapy, standard of care)<br>Patients undergo cryotherapy on day 0. | Procedure: cryotherapy<br>* Undergo cryotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in B cell response identified by Serametrix assay | 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. | Baseline to up to 3 months after cryotherapy | 
| Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot | 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. | Baseline to up to 3 months after cryotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PSA levels in serum samples |  | Up to 6 months after cryotherapy |