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Multi-Institutional Pilot Study to Evaluate Molecular Markers in Urine and Serum in the Early Detection of Prostate Cancer

40 Years
75 Years
Not Enrolling
Prostate Cancer

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Trial Information

Multi-Institutional Pilot Study to Evaluate Molecular Markers in Urine and Serum in the Early Detection of Prostate Cancer

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.

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.


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

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Methylation
  • Genes
  • Screening
  • Prospective
  • Diagnosis
  • Prostatic Neoplasms



Madigan Army Medical CenterTacoma, Washington  98431-5048