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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Intervention / Treatment: Biological: sargramostim; Procedure: cryotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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%

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Biological: sargramostim; Given subcutaneously; Other Names: Leukine; Prokine; GM-CSF; Procedure: cryotherapy; Undergo cryotherapy
Active Comparator: Arm II (cryotherapy, standard of care); Patients undergo cryotherapy on day 0.	Procedure: cryotherapy; Undergo cryotherapy

What is the study measuring?

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	Time Frame
Change in PSA levels in serum samples	Up to 6 months after cryotherapy

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: EDAP TMS S.A.
• Investigators: Principal Investigator: Al Barqawi, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Sargramostim
• Other Study ID Numbers: 14-0071.cc; 14-0071 (University of Colorado, Denver)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO