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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00984919
Enrollment
10
Registered
2009-09-25
Start date
2009-11-30
Completion date
2011-02-28
Last updated
2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer

Brief summary

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

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.

Interventions

OTHERhigh performance liquid chromatography
OTHERlaboratory biomarker analysis
OTHERmass spectrometry

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to 120 Years
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frame
Identification of 11-dh-TXB2 in the blood and urine2 to 4 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026