ProstateNCT00342433
Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes: A Methodologic Study
An observational study of Prostate, run by National Cancer Institute (NCI) at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate
- How many people
- 553 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 May 1999to 15 May 2020
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer cases diagnosed at the collaborating centers
Who may be able to join
- Subjects must be over age 18.
- Subjects must have a newly diagnosed prostate disease or condition.
- Subjects must not currently take hormones.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Fairfax Hospital
Falls Church, Virginia, 22046
Doctors Community Hospital
Lanham, Maryland
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
University of California, San Francisco
San Francisco, California, 94143
Washington Hospital Center
Washington D.C., District of Columbia, 20010
GW University Medical Center GW Hospital Center
Washington D.C., District of Columbia, 20037
About this study
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 serum/plasma 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, D.C. 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.
Read more
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.
Read the 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).
- Conditions
- Prostate
- Keywords
- Androgens, Serum, Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Localized Prostate Cancer cases | Cases enrolled between Jan 2000 and Apr 2004 at five locations. Study subject eligibility: Age >=18; scheduled for radical prostatectomy; and newly diagnosed with localized prostate cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraprostatic hormone concentrations
comparisons between circulating and intraprostatic hormones
Measured: Cross-sectional
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 start5 May 1999
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ProstateStudies 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael B Cook, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342433
- Sponsor's protocol ID
- 999999025
- Other IDs
- OH99-C-N025
- Status last verified
- May 2020
- First submitted
- 19 Jun 2006
- Last updated
- 20 May 2020
- Results posted
- No
Publications
Hsing AW. Hormones and prostate cancer: where do we go from here? J Natl Cancer Inst. 1996 Aug 21;88(16):1093-5. doi: 10.1093/jnci/88.16.1093. No abstract available.
PubMed 8757182Montie JE, Pienta KJ. Review of the role of androgenic hormones in the epidemiology of benign prostatic hyperplasia and prostate cancer. Urology. 1994 Jun;43(6):892-9. doi: 10.1016/0090-4295(94)90163-5.
PubMed 7515207Vatten LJ, Ursin G, Ross RK, Stanczyk FZ, Lobo RA, Harvei S, Jellum E. Androgens in serum and the risk of prostate cancer: a nested case-control study from the Janus serum bank in Norway. Cancer Epidemiol Biomarkers Prev. 1997 Nov;6(11):967-9.
PubMed 9367072
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes: A Methodologic Study
- ClinicalTrials.gov ID
- NCT00342433
- Acronym / sponsor ID
- 999999025
- Conditions
- Prostate
- Keywords
- Androgens, Serum, Tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 May 1999 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- 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.
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 serum/plasma 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, D.C. 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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localized Prostate Cancer cases | – | –Cases enrolled between Jan 2000 and Apr 2004 at five locations. Study subject eligibility: Age >=18; scheduled for radical prostatectomy; and newly diagnosed with localized prostate cancer. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer cases diagnosed at the collaborating centers
Key inclusion criteria (3 listed)
- Subjects must be over age 18.
- Subjects must have a newly diagnosed prostate disease or condition.
- Subjects must not currently take hormones.
Key exclusion criteria (0 listed)
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
Intraprostatic hormone concentrations
Time frame: Cross-sectional
comparisons between circulating and intraprostatic hormones
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 20 May 2020.
- Background: PubMed 8757182Hsing AW. Hormones and prostate cancer: where do we go from here? J Natl Cancer Inst. 1996 Aug 21;88(16):1093-5. doi: 10.1093/jnci/88.16.1093. No abstract available.
- Background: PubMed 7515207Montie JE, Pienta KJ. Review of the role of androgenic hormones in the epidemiology of benign prostatic hyperplasia and prostate cancer. Urology. 1994 Jun;43(6):892-9. doi: 10.1016/0090-4295(94)90163-5.
- Background: PubMed 9367072Vatten LJ, Ursin G, Ross RK, Stanczyk FZ, Lobo RA, Harvei S, Jellum E. Androgens in serum and the risk of prostate cancer: a nested case-control study from the Janus serum bank in Norway. Cancer Epidemiol Biomarkers Prev. 1997 Nov;6(11):967-9.
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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.
Michael B Cook, M.D. principal investigator
National Cancer Institute (NCI)
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate, run by National Cancer Institute (NCI) at 7 sites in 2 countries.
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 3 inclusion and 0 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 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, China. 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.
What does the primary outcome measure?
Intraprostatic hormone concentrations (time frame: Cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342433, which also lists 3 linked publications.
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 20 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.