Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340717
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2006-06-19
Brief Title:
Markers for Early Detection of Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multi-Institutional Pilot Study to Evaluate Molecular Markers in Urine and Serum in the Early Detection of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DC 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
Patients between 40 and 75 years of age who are referred to Howard University Hospital in Washington DC 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
Detailed Description:
In the US 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 eg tumor-specific gene methylation of GSTPI CD44 Annexin II and Caveolin 1 detectable in serum andor 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 4ngml 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 10000 normal cells and could serve to add value to current prostate cancer screening modalities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N187 | None | None | None |