Markers for Early Detection of Prostate Cancer
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00340717 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Markers for Early Detection of Prostate Cancer|
|Official Title ICMJE||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:
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.
|Detailed Description||In the U.S., screening by prostate-specific antigen (PSA) is widespread and considered to be an effective early detection screen for prostate cancer although there are some problems associated with its use. Only about 30-40% of men with elevated PSA are diagnosed with cancer on initial biopsy. The other 60-70% are diagnosed with either benign prostatic hyperplasia or low-or high-grade prostatic intraepithelial neoplasia (LGPIN or HGPIN). Due to their persistent elevated PSA levels, men undergo repeat biopsies where many are subsequently diagnosed with cancer (the false negative rate for biopsies with pathological diagnoses of benign or LGPIN has been reported to be 13-19% and for HGPIN from 50-70%). We propose to conduct a pilot study to evaluate whether (i) the addition of molecular markers (e.g., tumor-specific gene methylation of GSTPI, CD44, Annexin II, and Caveolin 1) detectable in serum and/or urine sediments after prostatic massage can improve the prediction of prostate cancer and (ii) addition of tumor-specific gene methylation detectable in core-needle biopsy specimens can improve the sensitivity of core-needle biopsy in the diagnosis of prostate cancer among patients screened at two Urology clinics located at Howard University, Washington, DC and Madigan Army Medical Center, Tacoma, WA. Preliminary studies have shown detection of hypermethylated genes in urine sediments after prostatic massage in men with elevated PSA (greater than 4ng/ml) improved the specificity of PSA from 73% to 98%. Further, DNA hypermethylation of tumor-specific genes was also identified in serum. In our laboratory, we have developed assays for evaluating DNA hypermethylation of several genes shown to be important in prostate carcinogenesis. These assays are highly sensitive (able to detect down to about 20 tumor cells with methylated DNA) and specific (can distinguish methylated from normal DNA from in a ratio of 1 tumor cell in 10,000 normal cells), and could serve to add value to current prostate cancer screening modalities.|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Prostate Cancer|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||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. Erratum in: Urology 1998 Mar;51(3):523.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
Patients with active of history of other malignancy (excluding non-melanoma skin cancer).
|Ages||40 Years to 75 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00340717|
|Other Study ID Numbers ICMJE||999903187, 03-C-N187|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP