This study is a clinical study to investigate and characterize the immune response profile to four different prostate cancer treatments (total cryotherapy, focal cryotherapy, Cyberknife SBRT, and radical prostatectomy) in patients with localized prostate cancer.
The immune system plays an important role in cancer, and there is evidence that different types of cancer treatment can elicit different responses from the body's immune system. This study is designed to look at immune markers in the blood and urine of patients undergoing four different types of prostate cancer treatment and compare the differences. Patients who have elected Total Cryotherapy (freezing of the entire prostate), focal cryotherapy (freezing only the side of the prostate affected by cancer), Cyberknife stereotactic body radiation therapy (SBRT) and Radical Prostatectomy (removal of the entire prostate) for the treatment of their prostate cancer will be eligible to participate in this study. The study is expected to enroll 40 patients, 10 patients per treatment group. The study includes a screening visit during which the subject will provide informed consent, and provide a blood sample and a urine sample. At 2-3 weeks following their scheduled treatment, they will again provide another blood and urine sample. At their regularly scheduled follow up at 3 months, they will again provide another blood and urine sample. These samples are collected for research purposes only, and the costs will be covered by the study grant account, without any additional cost to the patient. The investigators have determined that this study presents no more than minimal risk to patients due to the minimal risks involved with a blood draw and urine specimen collection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
NYU Winthrop Hospital
Mineola, New York, United States
Evaluate the change in blood cytokine profile
Cytokines to be evaluated include but are not limited to: TNF-alpha, IL-1b, IL2, IL-2 CD25 Receptor Soluble, IFN-gamma, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 and IL-13.
Time frame: Before treatment, 2-3 weeks post treatment, 3 months post treatment
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