Investigating and Characterizing the Immune Response to Prostate Cancer
NCT ID: NCT03331367
Last Updated: 2020-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-09-14
2020-02-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Total Cyrotherapy of the Prostate
Patients who will undergo total cryotherapy of the prostate will be evaluated for immune markers using a blood draw and urine sample collected at three timepoints (baseline, 2-3 weeks post cryotherapy, 3 months post cryotherapy)
Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
Focal Cryotherapy of the Prostate
Patients who will undergo focal cryotherapy of the prostate will be evaluated for immune markers using a blood draw and urine sample collected at three timepoints (baseline, 2-3 weeks post cryotherapy, 3 months post cryotherapy)
Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
Cyberknife SBRT of the Prostate
Patients who will undergo Cyberknife SBRT of the prostate will be evaluated for immune markers using a blood draw and urine sample collected at three timepoints (baseline, 2-3 weeks post Cyberknife, 3 months post Cyberknife)
Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
Radical Prostatectomy
Patients who will undergo a radical prostatectomy will be evaluated for immune markers using a blood draw and urine sample collected at three timepoints (baseline, 2-3 weeks post surgery, 3 months post surgery)
Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
Interventions
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Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
Eligibility Criteria
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Inclusion Criteria
* Histologically proven Prostate Carcinoma.
* Undergoing total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy for prostate cancer treatment.
Exclusion Criteria
* Has previously received cryotherapy for prostate cancer.
* Previous treatment with chemotherapy within the past 6 months.
* Previous treatment with radiation within the past 18 months.
* Has evidence of metastatic disease.
* Has a current or history within the past 6 months of alcohol and/or substance abuse which would impair participation in the study.
* Has a major medical disorder (i.e. uncontrolled diabetes, significant hepatic, renal or hematological disorders, recent stroke or myocardial infarction), in the opinion of the urologist, is an illness or complication which is not consistent with the protocol requirements.
* Is not willing to undergo the necessary follow-up for the trial period.
* Has known immunologic disease, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
18 Years
MALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Aaron E Katz, MD
Role: PRINCIPAL_INVESTIGATOR
NYU
Locations
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NYU Winthrop Hospital
Mineola, New York, United States
Countries
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Other Identifiers
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18-01696
Identifier Type: OTHER
Identifier Source: secondary_id
18-01696
Identifier Type: -
Identifier Source: org_study_id
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