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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898274
• Other study ID #: CASE11807
• Secondary ID: P30CA043703CASE1
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 8, 2016
• Start date: January 2008
• Est. completion date: May 2011

Study information

• Verified date: March 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Precancerous Condition
• Precancerous Conditions
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UHHS Chagrin Highlands Medical Center	Cleveland	Ohio
United States	University Suburban Health Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No