The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
2 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedStudy Start
First participant enrolled
October 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2020
CompletedFebruary 9, 2022
February 1, 2022
2.2 years
September 23, 2014
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in PSA levels in serum samples
Up to 6 months after cryotherapy
Study Arms (2)
Arm I (cryotherapy, sargramostim)
EXPERIMENTALPatients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
Arm II (cryotherapy, standard of care)
ACTIVE COMPARATORPatients undergo cryotherapy on day 0.
Interventions
Undergo cryotherapy
Given subcutaneously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- EDAP TMS S.A.collaborator
Study Sites (1)
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Al Barqawi
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2014
First Posted
September 26, 2014
Study Start
October 5, 2015
Primary Completion
December 1, 2017
Study Completion
December 21, 2020
Last Updated
February 9, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share