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

Primary Purpose

Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cryotherapy
sargramostim
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Prostate Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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%

Sites / Locations

  • University of Colorado Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (cryotherapy, sargramostim)

Arm II (cryotherapy, standard of care)

Arm Description

Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.

Patients undergo cryotherapy on day 0.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in PSA levels in serum samples

Full Information

First Posted
September 23, 2014
Last Updated
February 8, 2022
Sponsor
University of Colorado, Denver
Collaborators
EDAP TMS S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02250014
Brief Title
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
Official Title
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
EDAP TMS S.A.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (cryotherapy, sargramostim)
Arm Type
Experimental
Arm Description
Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
Arm Title
Arm II (cryotherapy, standard of care)
Arm Type
Active Comparator
Arm Description
Patients undergo cryotherapy on day 0.
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
Undergo cryotherapy
Intervention Type
Biological
Intervention Name(s)
sargramostim
Other Intervention Name(s)
GM-CSF, Leukine, Prokine
Intervention Description
Given subcutaneously
Primary Outcome Measure Information:
Title
Change in B cell response identified by Serametrix assay
Description
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.
Time Frame
Baseline to up to 3 months after cryotherapy
Title
Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot
Description
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.
Time Frame
Baseline to up to 3 months after cryotherapy
Secondary Outcome Measure Information:
Title
Change in PSA levels in serum samples
Time Frame
Up to 6 months after cryotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al Barqawi
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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