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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Precancerous Condition
• Intervention / Treatment: Other: immunoenzyme technique; Other: laboratory biomarker analysis

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay	Blood (5ml) will be drawn from subjects for use in the various assays.	at time of study entry
Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay	Blood (5ml) will be drawn from subjects for use in the various assays.	at time of study entry

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Sanjay Gupta, PhD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (ESTIMATE): May 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: prostate cancer; high grade prostatic intraepithelial neoplasia
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Precancerous Conditions
• Other Study ID Numbers: CASE11807 (OTHER: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract)