Prostate CancerNCT00340717
Markers for Early Detection of Prostate Cancer
An observational study of Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with active of history of other malignancy (excluding non-melanoma skin cancer).
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Methylation, Genes, Screening, Prospective, Diagnosis
- Medical subject headings
- Prostatic Neoplasms, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340717
- Sponsor's protocol ID
- 999903187
- Other IDs
- 03-C-N187
- Status last verified
- Sep 2006
- First submitted
- 19 Jun 2006
- Last updated
- 4 Mar 2008
- Results posted
- No
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. doi: 10.1016/s0090-4295(97)00620-1.
PubMed 9495696
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Institutional Pilot Study to Evaluate Molecular Markers in Urine and Serum in the Early Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00340717
- Acronym / sponsor ID
- 999903187
- Conditions
- Prostate Cancer
- Keywords
- Methylation, Genes, Screening, Prospective, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2003
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with active of history of other malignancy (excluding non-melanoma skin cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9495696Orozco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.