Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine samples from patients with prostate cancer and healthy volunteers.

Detailed Description
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OBJECTIVES: To identify a potential novel marker of prostate cancer in the blood and urine, 11-dh-TXB2, to be used as a screening tool for prostate cancer as well as in detection of early relapse in patients previously treated for early-stage prostate cancer. OUTLINE: Blood and urine samples are collected and analyzed for plasma and urinary 11-dh-TXB2 levels by HPLC and tandem-mass spectrometry.

Official Title
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Pilot Study of the Role of 11-dh-TXB2 in Prostate Cancer Screening and Diagnosis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: high performance liquid chromatography
* Other: laboratory biomarker analysis
* Other: mass spectrometry


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets one of the following criteria: Histopathologically confirmed prostate cancer meeting 1 of the following criteria: Newly diagnosed untreated disease Received prior local therapy (prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy) with no evidence of disease activity (defined as serum PSA < 0.4 ng/mL post therapy) and by imaging studies Experienced biochemical failure (defined as rise in serum PSA ≥ 0.4 ng/mL post therapy) Healthy volunteer (clinic patient with no history of clinically significant malignancies within the past 6 months) PATIENT CHARACTERISTICS: No clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy) No active prostatitis PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 30 days since prior and no concurrent regular antiplatelet agents (including aspirin, anagrelide, cilastazole, clopidogrel, dipyridamole, pentoxiphylline, sulfinpyrazone, or ticlopidine) More than 7 days since prior and no concurrent NSAIDs (including ibuprofen, celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, or tolmetin)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: high performance liquid chromatography|nan|
|Other: laboratory biomarker analysis|nan|
|Other: mass spectrometry|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of 11-dh-TXB2 in the blood and urine |  | 2 to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer