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

Barbara Ann Karmanos Cancer Institute

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: high performance liquid chromatography; Other: laboratory biomarker analysis; Other: mass spectrometry

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00984919

WSU-2009-058

P30CA022453 (U.S. NIH Grant/Contract)

CDR0000654093

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: Male

Ages: 40 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)