NCT00342433

Intraprostatic Androgenicity in Relation to Circulating Levels of Hormones and Polymorphisms of Hormone-Related Genes: A Methodologic Study

Completed Last updated 20 May 2020

What this trial tests

trial in Prostate in 553 participants. Completed in 15 May 2020.

Timeline

5 May 1999

Primary endpoint
15 May 2020

15 May 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	553
Start date	5 May 1999
Primary completion	15 May 2020
Estimated completion	15 May 2020
Sites	7 locations across China, United States

Conditions studied

• Prostate — all drugs for Prostate →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 100, male only, with Prostate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.