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

Recurrent Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250014
• Other study ID #: 14-0071.cc
• Secondary ID: 14-0071
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2015
• Est. completion date: December 21, 2020

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 21, 2020
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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%

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

Procedure:
• cryotherapy
Undergo cryotherapy

Biological:
• sargramostim
Given subcutaneously

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	EDAP TMS S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in PSA levels in serum samples		Up to 6 months after cryotherapy