- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340717
Markers for Early Detection of Prostate Cancer
Multi-Institutional Pilot Study to Evaluate Molecular Markers in Urine and Serum in the Early Detection of Prostate Cancer
This study will determine whether certain gene alterations can serve as markers for early detection of prostate cancer. Prostate cancer is often diagnosed by detecting high levels of a protein called prostate-specific antigen (PSA) in the blood. Other conditions can also cause elevated PSA levels, however, so that additional tests are needed to distinguish between benign and cancerous prostate conditions.
Patients between 40 and 75 years of age who are referred to Howard University Hospital in Washington, D.C., or Madigan Army Medical Center in Tacoma, Washington, for ultrasound and needle biopsy to diagnose prostate cancer may be eligible for this study.
Participants will undergo the following procedures at the time of the biopsy visit:
- Blood collection: Patients have 10 milliliters (2 teaspoons) of blood drawn.
- Prostate massage: Patients have a rectal examination and prostate massage. For the latter procedure, the physician lightly massages the prostate gland for about 15 seconds. After the massage, the patient provides a urine specimen.
- Biopsy: A small sample of tumor tissue is removed surgically for examination under the microscope.
Patients whose initial biopsy does not show cancer cells, but who are advised to have a repeat biopsy in the future will give a blood, urine, and biopsy specimen at the time of the next biopsy.
Patients who are diagnosed with prostate cancer and undergo surgery to remove the tumor will have a small sample of tumor tissue set aside for this study to look for substances that may help predict prostate cancer.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Washington
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Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Patients must be within 40-75 years of age.
Patients referred for diagnostic transrectal ultrasound and prostate needle biopsy.
Patients must be adults and capable of understanding and signing an informed consent form.
Patients must be willing to undergo a brief prostatic massage and provide a urine and serum specimen prior to diagnostic core needle biopsy.
EXCLUSION CRITERIA:
Patients with active of history of other malignancy (excluding non-melanoma skin cancer).
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999903187
- 03-C-N187
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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