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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00898274
First received: May 9, 2009
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Precancerous Condition
Prostate Cancer
 Other: immunoenzyme technique
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antioxidant Enzymes and Oxidative DNA Damage in Subjects With 'High-Risk' for Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at time of study entry ] [ Designated as safety issue: No ]
    Blood (5ml) will be drawn from subjects for use in the various assays.


Biospecimen Retention:   Samples With DNA

Blood samples from patients at high risk of developing prostate cancer and from healthy male participants.


Enrollment: 40
Study Start Date: January 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898274

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
University Suburban Health Center
Cleveland, Ohio, United States, 44121
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00898274     History of Changes
Other Study ID Numbers: CASE11807, P30CA043703, CASE11807
Study First Received: May 9, 2009
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
prostate cancer
high grade prostatic intraepithelial neoplasia

Additional relevant MeSH terms:
Precancerous Conditions
Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Prostatic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013