Prostate CancerNCT00007540
Study of Prostate Cancer in Black and White U.S. Veterans
An observational study of Prostate Cancer and Prostatic Neoplasms, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly 41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans and the second leading cancer among all Americans. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Sep 2000
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Veterans who undergo prostate biopsy where biopsy results are positive or PSA less than 10Ng/ml.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vamc - Chicago-Lakeside, Il
Chicago, Illinois, 60611
About this study
Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly 41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans and the second leading cancer among all Americans. The causes of prostate cancer and, particularly, the reasons for the unusually high incidence rates in African-Americans remain obscure. Dietary factors likely play a role in fatal cases, while hormones are also important in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the 1940?s, with androgen deprivation remaining as the cornerstone of therapy for advanced disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic sciences have produced clear insight into the etiologic role of hormones. However, recent observations regarding androgen receptor gene polymorphisms and their relation to endocrine expression and prostate cancer risk may be providing important clues as to how an etiologic role might be mediated at the molecular level. Thus, it is important to attempt to identify genetic markers of high-risk cancer patients for necessary screening and counseling efforts.
Read the detailed description
Primary Objectives: To evaluate the relationship between the length of the CAG repeat sequence occurring in the androgen receptor gene and major prostate cancer prognostic determinants (race, age, histologic grade and stage) at the time of diagnosis in black and white veterans.
Secondary Objectives: To create a secure, organized bank of DNA plasma samples obtained from newly diagnosed prostate cancer patients and assay the peripheral blood DNA for inherited polymorphisms of the androgen receptor gene.
Primary Outcomes: The primary outcomes are androgen receptor CAG repeat sequence length and stage of disease.
Intervention: N/A
Study Abstract: Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly 41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans and the second leading cancer among all Americans. The causes of prostate cancer and, particularly, the reasons for the unusually high incidence rates in African-Americans remain obscure. Dietary factors likely play a role in fatal cases, while hormones are also important in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the 1940's, with androgen deprivation remaining as the cornerstone of therapy for advanced disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic sciences have produced clear insight into the etiologic role of hormones. However, recent observations regarding androgen receptor gene polymorphisms and their relation to endocrine expression and prostate cancer risk may be providing important clues as to how an etiologic role might be mediated at the molecular level. Thus, it is important to attempt to identify genetic markers of high-risk cancer patients for necessary screening and counseling efforts.
It has been recently demonstrated that the androgen receptor functions as a ligand-dependent transcriptional regulator, and that this regulation is important in controlling prostate growth and apoptosis. Heightened androgenic stimulation, a potential by-product of shortened CAG repeat length, could potentially increase the risk of prostate cancer development and progression. In particular, a shorter CAG repeat sequence may be associated with cancers that have features of higher histologic grade, extraprostatic extension, and distant metastases (stage C or D). Recent evidence indicates that men with shorter CAG repeats are at particularly higher risk for distant metastatic and fatal prostate cancer. The results demonstrated that a shorter CAG repeat sequence in the androgen receptor gene predicted higher grade and advanced state of prostate cancer at diagnosis, metastatic disease, and mortality. However, these studies have been limited to whites since only a small number of African American men with prostate cancer were included.
Prostate cancer incidence varies between African-American and white men. African-American men have the highest known incidence rates in the world, 66% higher than white men in the U.S. The genetic findings described above raise the possibility that racial differences in the distribution of androgen receptor polymorphisms may account for the higher rate of prostate cancer, the more advanced disease, and the younger age at presentation in African-Americans.
This study created a cohort of prostate cancer patients who are well characterized with respect to histology, stage of diagnosis, and (over time) mortality. This study is generating data regarding the length of the CAG repeat sequence occurring in the androgen receptor gene and major prostate cancer prognostic determinants (histologic grade and state) at the time of diagnosis in black and white veterans. CAG repeat lengths on the androgen receptor gene were evaluated for a cohort of 145 African American and 150 white veterans with prostate cancer.
Results: Mean androgen receptor gene CAG repeat lengths for Caucasians was 21.9 versus 19.8 for African Americans, p=0.0001. However, a truncated CAG repeat length (CAG <= 18 versus CAG > 18) was not associated with advanced stage of cancer at diagnosis, higher PSA at diagnosis, or higher Gleason score (each with p>0.5).
Conclusion: The mean androgen receptor CAG repeat length was 2 repeats shorter for African American versus white prostate cancer patients. These findings raise concern that prostate cancers in African American men may be less sensitive to hormonal therapy than those in white men. These findings provide biologic rationale for clinical trials that evaluate the joint administration of chemotherapy and hormone therapy for African American men with advanced prostate cancer.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- Prostate cancer, CAG repeat sequence
- Medical subject headings
- Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2001 (estimated)
- Study startApr 1998
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007540
- Sponsor's protocol ID
- 709D
- Status last verified
- Feb 2003
- First submitted
- 29 Dec 2000
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prostate Cancer in Black and White U.S. Veterans
- ClinicalTrials.gov ID
- NCT00007540
- Acronym / sponsor ID
- 709D
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- Prostate cancer, CAG repeat sequence
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1998
- Study completion
- Sep 2000
- First posted
- 1 Jan 2001 (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.
Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly 41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans and the second leading cancer among all Americans. The causes of prostate cancer and, particularly, the reasons for the unusually high incidence rates in African-Americans remain obscure. Dietary factors likely play a role in fatal cases, while hormones are also important in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the 1940?s, with androgen deprivation remaining as the cornerstone of therapy for advanced disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic sciences have produced clear insight into the etiologic role of hormones. However, recent observations regarding androgen receptor gene polymorphisms and their relation to endocrine expression and prostate cancer risk may be providing important clues as to how an etiologic role might be mediated at the molecular level. Thus, it is important to attempt to identify genetic markers of high-risk cancer patients for necessary screening and counseling efforts.
Detailed description
Primary Objectives: To evaluate the relationship between the length of the CAG repeat sequence occurring in the androgen receptor gene and major prostate cancer prognostic determinants (race, age, histologic grade and stage) at the time of diagnosis in black and white veterans.
Secondary Objectives: To create a secure, organized bank of DNA plasma samples obtained from newly diagnosed prostate cancer patients and assay the peripheral blood DNA for inherited polymorphisms of the androgen receptor gene.
Primary Outcomes: The primary outcomes are androgen receptor CAG repeat sequence length and stage of disease.
Intervention: N/A
Study Abstract: Prostate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly 41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans and the second leading cancer among all Americans. The causes of prostate cancer and, particularly, the reasons for the unusually high incidence rates in African-Americans remain obscure. Dietary factors likely play a role in fatal cases, while hormones are also important in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the 1940's, with androgen deprivation remaining as the cornerstone of therapy for advanced disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic sciences have produced clear insight into the etiologic role of hormones. However, recent observations regarding androgen receptor gene polymorphisms and their relation to endocrine expression and prostate cancer risk may be providing important clues as to how an etiologic role might be mediated at the molecular level. Thus, it is important to attempt to identify genetic markers of high-risk cancer patients for necessary screening and counseling efforts.
It has been recently demonstrated that the androgen receptor functions as a ligand-dependent transcriptional regulator, and that this regulation is important in controlling prostate growth and apoptosis. Heightened androgenic stimulation, a potential by-product of shortened CAG repeat length, could potentially increase the risk of prostate cancer development and progression. In particular, a shorter CAG repeat sequence may be associated with cancers that have features of higher histologic grade, extraprostatic extension, and distant metastases (stage C or D). Recent evidence indicates that men with shorter CAG repeats are at particularly higher risk for distant metastatic and fatal prostate cancer. The results demonstrated that a shorter CAG repeat sequence in the androgen receptor gene predicted higher grade and advanced state of prostate cancer at diagnosis, metastatic disease, and mortality. However, these studies have been limited to whites since only a small number of African American men with prostate cancer were included.
Prostate cancer incidence varies between African-American and white men. African-American men have the highest known incidence rates in the world, 66% higher than white men in the U.S. The genetic findings described above raise the possibility that racial differences in the distribution of androgen receptor polymorphisms may account for the higher rate of prostate cancer, the more advanced disease, and the younger age at presentation in African-Americans.
This study created a cohort of prostate cancer patients who are well characterized with respect to histology, stage of diagnosis, and (over time) mortality. This study is generating data regarding the length of the CAG repeat sequence occurring in the androgen receptor gene and major prostate cancer prognostic determinants (histologic grade and state) at the time of diagnosis in black and white veterans. CAG repeat lengths on the androgen receptor gene were evaluated for a cohort of 145 African American and 150 white veterans with prostate cancer.
Results: Mean androgen receptor gene CAG repeat lengths for Caucasians was 21.9 versus 19.8 for African Americans, p=0.0001. However, a truncated CAG repeat length (CAG <= 18 versus CAG > 18) was not associated with advanced stage of cancer at diagnosis, higher PSA at diagnosis, or higher Gleason score (each with p>0.5).
Conclusion: The mean androgen receptor CAG repeat length was 2 repeats shorter for African American versus white prostate cancer patients. These findings raise concern that prostate cancers in African American men may be less sensitive to hormonal therapy than those in white men. These findings provide biologic rationale for clinical trials that evaluate the joint administration of chemotherapy and hormone therapy for African American men with advanced prostate cancer.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 21 Jan 2009.
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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 and Prostatic Neoplasms, run by US Department of Veterans Affairs 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?
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 21 Jan 2009. 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?
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 21 Jan 2009.