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


N/A
40 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Identification of 11-dh-TXB2 in the blood and urine

Outcome Time Frame:

2 to 4 months

Safety Issue:

No

Principal Investigator

Elisabeth I. Heath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000654093

NCT ID:

NCT00984919

Start Date:

November 2009

Completion Date:

February 2011

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201