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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898274
Enrollment
40
Registered
2009-05-12
Start date
2008-01-31
Completion date
2011-05-31
Last updated
2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precancerous Condition, Prostate Cancer

Keywords

prostate cancer, high grade prostatic intraepithelial neoplasia

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.

Detailed description

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.

Interventions

OTHERimmunoenzyme 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.

OTHERlaboratory 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assayat time of study entryBlood (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 assayat time of study entryBlood (5ml) will be drawn from subjects for use in the various assays.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026