Markers for Early Detection of Prostate Cancer

NCT00340717 | Completed

• 2 other identifiers: 99990318703-C-N187
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Methylation; Genes; Screening; Prospective; Diagnosis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with active of history of other malignancy (excluding non-melanoma skin cancer).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (1)

• Orozco R, O'Dowd G, Kunnel B, Miller MC, Veltri RW. Observations on pathology trends in 62,537 prostate biopsies obtained from urology private practices in the United States. Urology. 1998 Feb;51(2):186-95. doi: 10.1016/s0090-4295(97)00620-1.

  PMID: 9495696 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: May 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2006-09

Locations

US (1)