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

NCT00898274 | Completed DMC

• 2 other identifiers: CASE11807P30CA043703
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Precancerous Condition; Prostate Cancer

Keywords

prostate cancer; high grade prostatic intraepithelial neoplasia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

High risk for developing prostate cancer

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

Other: immunoenzyme technique; Other: laboratory biomarker analysis

Healthy participants

Aged matched healthy participants

Other: immunoenzyme technique; Other: laboratory biomarker analysis

Interventions

immunoenzyme technique OTHER

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.

Healthy participants; High risk for developing prostate cancer

laboratory biomarker analysis OTHER

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.

Healthy participants; High risk for developing prostate cancer

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Suburban Health Center

Cleveland, Ohio, 44121, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from patients at high risk of developing prostate cancer and from healthy male participants.

MeSH Terms

Conditions

Precancerous Conditions; Prostatic Neoplasms

Interventions

Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Sanjay Gupta, PhD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (3)