Clinical trial NCT03331367: Investigating and Characterizing the Immune Response to Prostate Cancer
Official title: Investigating and Characterizing the Immune Response to Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Cryotherapy
Radiation
Prostatectomy
Immune Response
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study involves four arms consisting of patients who have undergone either total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Evaluate the change in blood cytokine profile
timeFrame: Before treatment, 2-3 weeks post treatment, 3 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
Study officials:
affiliation: NYU
name: Aaron E Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: