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


N/A
45 Years
65 Years
Open (Enrolling)
Male
Precancerous Condition, Prostate Cancer

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Trial Information

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


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.

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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay

Outcome Description:

Blood (5ml) will be drawn from subjects for use in the various assays.

Outcome Time Frame:

at time of study entry

Safety Issue:

No

Principal Investigator

Sanjay Gupta, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE11807

NCT ID:

NCT00898274

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Precancerous Condition
  • Prostate Cancer
  • prostate cancer
  • high grade prostatic intraepithelial neoplasia
  • Precancerous Conditions
  • Prostatic Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
University Suburban Health Center South Euclid, Ohio  44121