Markers for Early Detection of Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00340717|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : March 4, 2008
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.
|Condition or disease|
|Study Type :||Observational|
|Enrollment :||100 participants|
|Official Title:||Multi-Institutional Pilot Study to Evaluate Molecular Markers in Urine and Serum in the Early Detection of Prostate Cancer|
|Study Start Date :||May 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340717
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|