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Investigating and Characterizing the Immune Response to Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331367
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Blood draw Procedure: Urine sample Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study involves four arms consisting of patients who have undergone either total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating and Characterizing the Immune Response to Prostate Cancer
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: 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)
Procedure: Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.

Procedure: Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.

Active Comparator: 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)
Procedure: Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.

Procedure: Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.

Active Comparator: 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)
Procedure: Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.

Procedure: Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.

Active Comparator: 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)
Procedure: Blood draw
Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.

Procedure: Urine sample
Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.




Primary Outcome Measures :
  1. Evaluate the change in blood cytokine profile [ Time Frame: Before treatment, 2-3 weeks post treatment, 3 months post treatment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is willing and able to freely sign informed consent to enroll in the study.
  • Histologically proven Prostate Carcinoma.
  • Undergoing total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy for prostate cancer treatment.

Exclusion Criteria:

  • Has previously had a radical prostatectomy for prostate cancer.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331367


Locations
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United States, New York
NYU Winthrop Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Aaron E Katz, MD NYU
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03331367    
Other Study ID Numbers: 18-01696
18-01696 ( Other Identifier: NYU Langone Institutional Review Board )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Cryotherapy
Radiation
Prostatectomy
Immune Response
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases