Investigating and Characterizing the Immune Response to Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Blood draw; Procedure: Urine sample

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before treatment, 2-3 weeks post treatment, 3 months post treatment

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Aaron E Katz, MD, NYU

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2017
• Primary Completion (ACTUAL): February 25, 2020
• Study Completion (ACTUAL): February 25, 2020

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Immune Response; Cryotherapy; Prostatectomy; Radiation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 18-01696 (OTHER: NYU Langone Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No