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

NCT00342433 | Completed

• 2 other identifiers: 999999025OH99-C-N025
• Study Type: observational
• Target: 553
• Locations: 2 countries
• Sites: 7

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 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.

Conditions

Prostate

Keywords

Androgens; Serum; Tissue

Outcome Measures

Primary Outcomes (1)

• Intraprostatic hormone concentrations

  comparisons between circulating and intraprostatic hormones

  Cross-sectional

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer cases diagnosed at the collaborating centers

You may qualify if:

• Subjects must be over age 18.
• Subjects must have a newly diagnosed prostate disease or condition.
• Subjects must not currently take hormones.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (7)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

GW University Medical Center GW Hospital Center

Washington D.C., District of Columbia, 20037, United States

Location

Doctors Community Hospital

Lanham, Maryland, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Location

Fairfax Hospital

Falls Church, Virginia, 22046, United States

Location

Shanghai Cancer Institute

Shanghai, China

Location

Related Publications (3)

• 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.

  PMID: 8757182 BACKGROUND

• Montie 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.

  PMID: 7515207 BACKGROUND

• Vatten 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.

  PMID: 9367072 BACKGROUND

Study Officials

• Michael B Cook, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: May 5, 1999
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

US (6); CN (1)