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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984919
• Other study ID #: CDR0000654093
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: February 12, 2016
• Start date: November 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2016
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 120 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

• mass spectrometry

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of 11-dh-TXB2 in the blood and urine		2 to 4 months	No