Investigating and Characterizing the Immune Response to Prostate Cancer

NCT03331367 | Completed DMC

• 1 other identifier: 18-01696
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Cryotherapy; Radiation; Prostatectomy; Immune Response

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Total Cyrotherapy of the Prostate

ACTIVE COMPARATOR

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; Procedure: Urine sample

Focal Cryotherapy of the Prostate

ACTIVE COMPARATOR

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; Procedure: Urine sample

Cyberknife SBRT of the Prostate

ACTIVE COMPARATOR

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; Procedure: Urine sample

Radical Prostatectomy

ACTIVE COMPARATOR

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; Procedure: Urine sample

Interventions

Blood draw PROCEDURE

Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.

Cyberknife SBRT of the Prostate; Focal Cryotherapy of the Prostate; Radical Prostatectomy; Total Cyrotherapy of the Prostate

Urine sample PROCEDURE

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; Focal Cryotherapy of the Prostate; Radical Prostatectomy; Total Cyrotherapy of the Prostate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Aaron E Katz, MD

  NYU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study involves four arms consisting of patients who have undergone either total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: September 14, 2017
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)