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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Precancerous Condition; Prostate Cancer

Treatments: Other: immunoenzyme technique; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898274

P30CA043703 (U.S. NIH Grant/Contract)

CASE11807 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

40 participants in 2 patient groups

High risk for developing prostate cancer

Description:

Male subjects age 45-65 at high risk for developing prostate cancer.

Treatment:

Other: laboratory biomarker analysis

Other: immunoenzyme technique

Healthy participants

Description:

Aged matched healthy participants

Treatment:

Other: laboratory biomarker analysis

Other: immunoenzyme technique