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

NCT ID: NCT02250014

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-05
• Study Completion Date: 2020-12-21

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.

Conditions

Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (cryotherapy, sargramostim)

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

Group Type: EXPERIMENTAL

cryotherapy

Intervention Type: PROCEDURE

Undergo cryotherapy

sargramostim

Intervention Type: BIOLOGICAL

Given subcutaneously

Arm II (cryotherapy, standard of care)

Patients undergo cryotherapy on day 0.

Group Type: ACTIVE_COMPARATOR

cryotherapy

Intervention Type: PROCEDURE

Undergo cryotherapy

Interventions

cryotherapy

Undergo cryotherapy

Intervention Type: PROCEDURE

sargramostim

Given subcutaneously

Intervention Type: BIOLOGICAL

Other Intervention Names

GM-CSF; Leukine; Prokine

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%

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

EDAP TMS S.A.

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Al Barqawi

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Cancer Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

14-0071

Identifier Type: OTHER

Identifier Source: secondary_id

14-0071.cc

Identifier Type: -

Identifier Source: org_study_id