Clinical trial NCT00898274: Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
Official title: Antioxidant Enzymes and Oxidative DNA Damage in Subjects With 'High-Risk' for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precancerous Condition
Prostate Cancer
Keywords: prostate cancer
high grade prostatic intraepithelial neoplasia
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: 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.

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 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)

Primary outcomes:
measure: Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay
timeFrame: at time of study entry
measure: Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay
timeFrame: at time of study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Suburban Health Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Sanjay Gupta, PhD
role: STUDY_CHAIR
References: