Clinical trial · Observational
Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
Antioxidant Enzymes and Oxidative DNA Damage in Subjects With 'High-Risk' for Prostate Cancer
NCT00898274CI-TRIAL-00021267completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Condition | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- High risk for developing prostate cancer
- description
- Male subjects age 45-65 at high risk for developing prostate cancer.
- interventionNames
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
- label
- Healthy participants
- description
- Aged matched healthy participants
- interventionNames
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay
- timeFrame
- at time of study entry
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.