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NCT00342433 · ClinicalTrials.gov registry record
Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes: A Methodologic Study
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 553
- Enrollment target
NCT00342433: Completed study, sponsored by National Cancer Institute (NCI).
NCT00342433 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 553 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00342433 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 553 participants
- Enrollment target
Study 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 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 ti
Primary Outcome
comparisons between circulating and intraprostatic hormones
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 553 participants |
| Start Date | 1999-05-05 |
| Est. Completion | 2020-05-15 |
What the finished NCT00342433 record still lists
NCT00342433 is an observational study that tracks outcomes without assigning an intervention. The registered 553 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00342433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00342433 about?
NCT00342433 is a clinical study titled "Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes: A Methodologic 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 s...
What is the current status of trial NCT00342433?
This trial is currently completed. The enrollment target is 553 participants. The study started on 1999-05-05. Estimated completion is 2020-05-15.
Who is sponsoring clinical trial NCT00342433?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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