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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 1

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

Treatments: Procedure: cryotherapy; Biological: sargramostim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02250014

14-0071 (Other Identifier)

14-0071.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Arm I (cryotherapy, sargramostim)

Experimental group

Description:

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

Treatment:

Biological: sargramostim

Procedure: cryotherapy

Arm II (cryotherapy, standard of care)

Active Comparator group

Description:

Patients undergo cryotherapy on day 0.

Treatment:

Procedure: cryotherapy