Clinical trial NCT02250014: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: EDAP TMS S.A.
First posted: 2014-09-26
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Change in B cell response identified by Serametrix assay
timeFrame: Baseline to up to 3 months after cryotherapy
measure: Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot
timeFrame: Baseline to up to 3 months after cryotherapy
Secondary outcomes:
measure: Change in PSA levels in serum samples
timeFrame: Up to 6 months after cryotherapy
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Al Barqawi
role: PRINCIPAL_INVESTIGATOR
References: