Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-05 @ 9:34 PM
Study NCT ID:
NCT03331367
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating and Characterizing the Immune Response to Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study involves four arms consisting of patients who have undergone either total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the change in blood cytokine profile', 'timeFrame': 'Before treatment, 2-3 weeks post treatment, 3 months post treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryotherapy', 'Radiation', 'Prostatectomy', 'Immune Response'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nPatients 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is willing and able to freely sign informed consent to enroll in the study.\n* Histologically proven Prostate Carcinoma.\n* Undergoing total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy for prostate cancer treatment.\n\nExclusion Criteria:\n\n* Has previously had a radical prostatectomy for prostate cancer.\n* Has previously received cryotherapy for prostate cancer.\n* Previous treatment with chemotherapy within the past 6 months.\n* Previous treatment with radiation within the past 18 months.\n* Has evidence of metastatic disease.\n* Has a current or history within the past 6 months of alcohol and/or substance abuse which would impair participation in the study.\n* 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.\n* Is not willing to undergo the necessary follow-up for the trial period.\n* Has known immunologic disease, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.'}, 'identificationModule': {'nctId': 'NCT03331367', 'briefTitle': 'Investigating and Characterizing the Immune Response to Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Investigating and Characterizing the Immune Response to Prostate Cancer', 'orgStudyIdInfo': {'id': '18-01696'}, 'secondaryIdInfos': [{'id': '18-01696', 'type': 'OTHER', 'domain': 'NYU Langone Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total Cyrotherapy of the Prostate', 'description': '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)', 'interventionNames': ['Procedure: Blood draw', 'Procedure: Urine sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Focal Cryotherapy of the Prostate', 'description': '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)', 'interventionNames': ['Procedure: Blood draw', 'Procedure: Urine sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyberknife SBRT of the Prostate', 'description': '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)', 'interventionNames': ['Procedure: Blood draw', 'Procedure: Urine sample']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radical Prostatectomy', 'description': '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)', 'interventionNames': ['Procedure: Blood draw', 'Procedure: Urine sample']}], 'interventions': [{'name': 'Blood draw', 'type': 'PROCEDURE', 'description': 'Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.', 'armGroupLabels': ['Cyberknife SBRT of the Prostate', 'Focal Cryotherapy of the Prostate', 'Radical Prostatectomy', 'Total Cyrotherapy of the Prostate']}, {'name': 'Urine sample', 'type': 'PROCEDURE', 'description': 'Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.', 'armGroupLabels': ['Cyberknife SBRT of the Prostate', 'Focal Cryotherapy of the Prostate', 'Radical Prostatectomy', 'Total Cyrotherapy of the Prostate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Winthrop Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}], 'overallOfficials': [{'name': 'Aaron E Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}