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Completed

NCT Number: NCT00898274

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

immunoenzyme technique

Other

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.

laboratory biomarker analysis

Other

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.

Primary outcomes

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

    Time frame: at time of study entry

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

  2. Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay

    Time frame: at time of study entry

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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 12, 2009
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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