Investigating and Characterizing the Immune Response to Prostate Cancer

Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 14, 2017
End Date:December 2019
Contact:Amanda L Le Sueur, PhD

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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.

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.

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

- 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.
We found this trial at
259 1st Street
Mineola, New York 11501
Phone: 516-535-1900
Mineola, NY
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