The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
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Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy treatment for prostate cancer.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (cryotherapy, sargramostim) Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12. |
Procedure: cryotherapy
Undergo cryotherapy
Biological: sargramostim
Given subcutaneously
Other Names:
|
| Active Comparator: Arm II (cryotherapy, standard of care) Patients undergo cryotherapy on day 0. |
Procedure: cryotherapy
Undergo cryotherapy
|
Outcome Measures
Primary Outcome Measures
- 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
- Change in PSA levels in serum samples [Up to 6 months after cryotherapy]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate
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Patients who are diagnosed with clinical stage T1a -T2c prostate cancer
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Gleason score sum of less than or equal to 7
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Prostate-specific antigen (PSA) < 20 ng/dl
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Patient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreement
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Patients must have a life expectancy of at least one year
Exclusion Criteria:
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Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeast
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Anticipated blood donation within the next 90 days
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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)
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Any history of current or within the past 48 hours of acute or chronic bacterial, fungal or viral infectious disease
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Documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood (>= 10%) in the past 6 months
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Previous organ transplant
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Immunosuppression including primary, secondary, iatrogenic and idiopathic
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Other serious diseases (hematological, hepatic, renal, respiratory, central nervous system, autoimmune or psychiatric)
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Enrollment in other studies for any disease in the past 30 days
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Diagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC) of skin
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Prior transurethral resection of the prostate with a large tissue defect (at the discretion of the investigator)
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History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
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Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment
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Patients with a Hemoglobin of less than 12%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- EDAP TMS S.A.
Investigators
- Principal Investigator: Al Barqawi, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-0071.cc
- 14-0071