Clinical trial NCT00984919: Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers
Official title: Pilot Study of the Role of 11-dh-TXB2 in Prostate Cancer Screening and Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-25
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer clinic

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.

Eligibility 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)

Primary outcomes:
measure: Identification of 11-dh-TXB2 in the blood and urine
timeFrame: 2 to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Elisabeth I. Heath, MD
role: PRINCIPAL_INVESTIGATOR
References: