Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants



Status:Completed
Conditions:Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:45 - 65
Updated:4/21/2016
Start Date:January 2008
End Date:May 2011

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Antioxidant Enzymes and Oxidative DNA Damage in Subjects With 'High-Risk' for Prostate Cancer

RATIONALE: Studying samples of blood in the laboratory from patients who are at high risk of
developing prostate cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from patients at high risk of
developing prostate cancer and from healthy male participants.

OBJECTIVES:

- To determine whether there are any changes in pro-oxidant-antioxidant profiles in
patients who are at high risk for developing prostate cancer.

- To compare the profiles of these patients with those of healthy controls.

OUTLINE: Participants undergo blood sample collection. Samples are used to measure levels of
antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase,
superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA
damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and
8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay,
and enzyme-linked immunosorbent assay.

PROJECTED ACCRUAL: A total of 40 participants (20 at high risk for developing prostate
cancer and 20 healthy controls) will be accrued for this study.

DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- Patient at high risk for developing prostate cancer, due to 1 of the following
risk factors:

- Histologically confirmed proliferative inflammatory atrophy and/or
high-grade prostatic intraepithelial neoplasia lesions accompanied by
chronic intraprostatic inflammation

- Abnormality observed during digital rectal exam or transrectal
ultrasonography

- Continued elevated age-adjusted prostate-specific antigen (PSA) meeting at
least 1 of the following criteria:

- Screening PSA > 4.0 ng/mL

- Free PSA < 18%

- PSA velocity > 0.75 ng/mL within the past year

- Healthy volunteer meeting the following criteria:

- Age-matched

- Normal PSA level (≤ 2.1 ng/mL)

- Normal digital rectal exam

- No prostatitis or benign prostate hyperplasia

- No urinary symptoms (diagnosed or undiagnosed)

- No diagnosis of cancer

PATIENT CHARACTERISTICS:

Patients and healthy controls:

- No chronic inflammatory conditions, especially those for which regular use of
non-steroidal anti-inflammatory medications (NSAIDs) is prescribed/recommended,
including any of the following:

- Coronary heart disease

- Chronic obstructive pulmonary disease (COPD)

- Psoriasis

- Pelvic inflammatory disease

- Multiple sclerosis

- Arthritis

- Lupus

- Hashimoto thyroiditis

- Inflammatory bowel disease (i.e., ulcerative colitis or Crohn disease)

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy or surgery to the prostate (healthy controls)
We found this trial at
3
sites
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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Cleveland, Ohio 44121
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Cleveland, OH
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Cleveland, OH
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