Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342433
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2006-06-19
Brief Title:
Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes A Methodologic Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes A Methodologic Study
Status:
COMPLETED
Status Verified Date:
2020-05
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:
Although compelling evidence from laboratory studies suggests that androgens play a major role in prostate carcinogenesis epidemiologic studies in humans almost exclusively serologic studies have been unable to confirm the hormonal hypothesis The major limitation in these serologic studies may stem from difficulty in measuring androgenicity directly at the target site - the prostate If circulating hormones do not reflect intraprostatic hormone levels or androgenicity it is not clear how we should interpret results from serumplasma measurements and it is unlikely that future serologic studies can clarify the role of hormones in prostate cancer etiology
This study is a comprehensive methodologic study designed to collect venous blood and prostatic tissue from 650 patients 100 Chinese 500 American and 50 Italian undergoing prostatic surgery radical prostatectomy cystoprostatectomy or transurethral resection of the prostate in order to correlate prostate tissue with serum hormone levels and with polymorphisms of hormone-related genes including the androgen receptor and SRD5A2 the gene encoding 5-alpha-reductase Type II and to examine characteristics such as age smoking body size that might affect serum-tissue correlation We plan to study the following hormones testosterone dihydrotestosterone androstenedione androstandediol glucuronide estradiol estrone and estrone sulfate Levels of androgen receptor and its associated protein in prostatic tissue will also be measured to provide a better estimate of total intraprostatic androgenicity We also plan to collect saliva from 100 of these cases in the Washington DC area and 100 of these cases in China to assess whether this non-invasive tissue collection method is valid for hormone measurements Finally urine collection from 100 of these Chinese men is planned for study of androgen metabolites
Additionally we plan to include 200 Chinese subjects for blood collection without tumor tissue for gene polymorphism studies bringing the total number of subjects enrolled to 850
For the 650 subjects providing prostate tissue 30-ml of fasting blood will be collected for hormone and polymorphism analyses and tissue will be collected at surgery A 15-minute interview will be conducted to elicit information on demographic characeristics tobacco and alcohol use body size and medical history
The proposed methodologic study will be the first of its kind to investigate androgenicity in target tissues directly and the correlation of target tissue androgenicity with circulating levels of hormones and polymorphisms of hormone-related genes in a well-designed epidemiologic study This study will provide critical information to guide future analytic studies on hormones and prostate cancer
This study is a comprehensive methodologic study designed to collect venous blood and prostatic tissue from 650 patients 100 Chinese 500 American and 50 Italian undergoing prostatic surgery radical prostatectomy cystoprostatectomy or transurethral resection of the prostate in order to correlate prostate tissue with serum hormone levels and with polymorphisms of hormone-related genes including the androgen receptor and SRD5A2 the gene encoding 5-alpha-reductase Type II and to examine characteristics such as age smoking body size that might affect serum-tissue correlation We plan to study the following hormones testosterone dihydrotestosterone androstenedione androstandediol glucuronide estradiol estrone and estrone sulfate Levels of androgen receptor and its associated protein in prostatic tissue will also be measured to provide a better estimate of total intraprostatic androgenicity We also plan to collect saliva from 100 of these cases in the Washington DC area and 100 of these cases in China to assess whether this non-invasive tissue collection method is valid for hormone measurements Finally urine collection from 100 of these Chinese men is planned for study of androgen metabolites
Additionally we plan to include 200 Chinese subjects for blood collection without tumor tissue for gene polymorphism studies bringing the total number of subjects enrolled to 850
For the 650 subjects providing prostate tissue 30-ml of fasting blood will be collected for hormone and polymorphism analyses and tissue will be collected at surgery A 15-minute interview will be conducted to elicit information on demographic characeristics tobacco and alcohol use body size and medical history
The proposed methodologic study will be the first of its kind to investigate androgenicity in target tissues directly and the correlation of target tissue androgenicity with circulating levels of hormones and polymorphisms of hormone-related genes in a well-designed epidemiologic study This study will provide critical information to guide future analytic studies on hormones and prostate cancer
Detailed Description:
Although androgens male hormones have been the central hypothesis in prostate cancer etiology for decades epidemiologic studies in humans have not been able to confirm this hormonal hypothesis Most of the studies used sere blood to examine the relationships of circulating hormones with subsequent prostate cancer risk However it is possible that circulating levels of hormones may not reflect intraprostatic and androgenic activity accurately
To gain further insights and to provide directions for future epidemiologic studies the National Cancer Institute NCI is conducting a comprehensive methodological study called Intraprostatic androgenicity in relation to circulating levels of hormone and polymorphisms of hormone-related genes a methodologic study The specific aims of this study are
to correlate circulating levels of androgens and estrogens with tissue levels including testosterone DHT DHT sulfate androstenedione androstanediol glucuronide estradiol estrone and estrone sulfate
to determine whether the serum-tissue correlation is mediated by age race and selected epidemiologic factors such as smoking and body size
to determine whether tissue hormone levels correlate with polymorphisms of certain hormone-related genes including androgen receptor AR and SRD5A2 and
to correlate circulating levels of hormones with intraprostatic androgenicity as defined by the combined levels of tissue hormones androgen receptor and its associated protein ARA70
To gain further insights and to provide directions for future epidemiologic studies the National Cancer Institute NCI is conducting a comprehensive methodological study called Intraprostatic androgenicity in relation to circulating levels of hormone and polymorphisms of hormone-related genes a methodologic study The specific aims of this study are
to correlate circulating levels of androgens and estrogens with tissue levels including testosterone DHT DHT sulfate androstenedione androstanediol glucuronide estradiol estrone and estrone sulfate
to determine whether the serum-tissue correlation is mediated by age race and selected epidemiologic factors such as smoking and body size
to determine whether tissue hormone levels correlate with polymorphisms of certain hormone-related genes including androgen receptor AR and SRD5A2 and
to correlate circulating levels of hormones with intraprostatic androgenicity as defined by the combined levels of tissue hormones androgen receptor and its associated protein ARA70
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 |
|---|---|---|---|
| OH99-C-N025 | None | None | None |