Trial | NCT02250014  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

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

  • Intervention/Treatment

    sargramostim ...

  • Study Participants

    19
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.
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 Started
Oct 05
2015
Primary Completion
Dec 01
2017
Study Completion
Dec 21
2020
Last Update
Feb 09
2022

Procedure cryotherapy

Undergo cryotherapy

Biological sargramostim

Given subcutaneously

  • Other names: GM-CSF, Leukine, Prokine

Arm I (cryotherapy, sargramostim) Experimental

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

Arm II (cryotherapy, standard of care) Active Comparator

Patients undergo cryotherapy on day 0.

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%
No Results Posted