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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Precancerous Condition, Prostate Cancer

Intervention / Treatment
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* Other: immunoenzyme technique
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk for developing prostate cancer<br>Male subjects age 45-65 at high risk for developing prostate cancer. | Other: immunoenzyme technique<br>* 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.<br>Other: laboratory biomarker analysis<br>* 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.<br>|
| Healthy participants<br>Aged matched healthy participants | Other: immunoenzyme technique<br>* 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.<br>Other: laboratory biomarker analysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay | Blood (5ml) will be drawn from subjects for use in the various assays. | at time of study entry | 
| Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay | Blood (5ml) will be drawn from subjects for use in the various assays. | at time of study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, high grade prostatic intraepithelial neoplasia