Status:
COMPLETED
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
EDAP TMS S.A.
Conditions:
Recurrent Prostate Cancer
Stage I Prostate Cancer
Eligibility:
MALE
18-85 years
Phase:
PHASE1
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 fro...
Detailed Description
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) p...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
October 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02250014
Start Date
October 5 2015
End Date
December 21 2020
Last Update
February 9 2022
Active Locations (1)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045