Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
OBJECTIVES:
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To determine whether there are any changes in pro-oxidant-antioxidant profiles in patients who are at high risk for developing prostate cancer.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High risk for developing prostate cancer Male subjects age 45-65 at high risk for developing prostate cancer. |
Other: immunoenzyme technique
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.
Other: laboratory biomarker analysis
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.
|
| Healthy participants Aged matched healthy participants |
Other: immunoenzyme technique
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.
Other: laboratory biomarker analysis
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.
|
Outcome Measures
Primary Outcome Measures
- Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay [at time of study entry]
Blood (5ml) will be drawn from subjects for use in the various assays.
- Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay [at time of study entry]
Blood (5ml) will be drawn from subjects for use in the various assays.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Meets 1 of the following criteria:
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Patient at high risk for developing prostate cancer, due to 1 of the following risk factors:
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Histologically confirmed proliferative inflammatory atrophy and/or high-grade prostatic intraepithelial neoplasia lesions accompanied by chronic intraprostatic inflammation
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Abnormality observed during digital rectal exam or transrectal ultrasonography
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Continued elevated age-adjusted prostate-specific antigen (PSA) meeting at least 1 of the following criteria:
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Screening PSA > 4.0 ng/mL
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Free PSA < 18%
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PSA velocity > 0.75 ng/mL within the past year
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Healthy volunteer meeting the following criteria:
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Age-matched
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Normal PSA level (≤ 2.1 ng/mL)
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Normal digital rectal exam
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No prostatitis or benign prostate hyperplasia
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No urinary symptoms (diagnosed or undiagnosed)
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No diagnosis of cancer
PATIENT CHARACTERISTICS:
Patients and healthy controls:
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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:
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Coronary heart disease
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Chronic obstructive pulmonary disease (COPD)
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Psoriasis
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Pelvic inflammatory disease
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Multiple sclerosis
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Arthritis
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Lupus
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Hashimoto thyroiditis
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Inflammatory bowel disease (i.e., ulcerative colitis or Crohn disease)
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or surgery to the prostate (healthy controls)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 2 | University Suburban Health Center | Cleveland | Ohio | United States | 44121 |
| 3 | UHHS Chagrin Highlands Medical Center | Cleveland | Ohio | United States | 44122 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Sanjay Gupta, PhD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE11807
- P30CA043703
- CASE11807