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

Completed

• Conditions: Precancerous Condition; Prostate Cancer
• Interventions: Other: immunoenzyme technique; Other: laboratory biomarker analysis

• Registration Number: NCT00898274
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk for developing prostate cancer	immunoenzyme technique	Male subjects age 45-65 at high risk for developing prostate cancer.
High risk for developing prostate cancer	laboratory biomarker analysis	Male subjects age 45-65 at high risk for developing prostate cancer.
Healthy participants	immunoenzyme technique	Aged matched healthy participants
Healthy participants	laboratory biomarker analysis	Aged matched healthy participants

Primary Outcome Measures

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

Trial Locations

Locations (3)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

University Suburban Health Center; 🇺🇸 Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center; 🇺🇸 Cleveland, Ohio, United States