Status:
COMPLETED
Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Precancerous Condition
Prostate Cancer
Eligibility:
MALE
45-65 years
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 ...
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 patien...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00898274
Start Date
January 1 2008
End Date
May 1 2011
Last Update
March 9 2016
Active Locations (3)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
University Suburban Health Center
Cleveland, Ohio, United States, 44121
3
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122