Prostate Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

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)

Study is for people with:

Prostate Cancer

Estimated Enrollment:

40

Study ID:

NCT00898274

Recruitment Status:

Completed

Sponsor:

Case Comprehensive Cancer Center

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There are 3 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

40

Study ID:

NCT00898274

Recruitment Status:

Completed

Sponsor:


Case Comprehensive Cancer Center

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