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Sponsors and Collaborators: |
Wageningen University World Cancer Research Fund |
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Information provided by: | Wageningen University |
ClinicalTrials.gov Identifier: | NCT00446901 |
The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.
Condition | Intervention |
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Prostatic Neoplasms Prostate Cancer |
Drug: selenium (selenized yeast) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-availability Study |
Official Title: | Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression |
Estimated Enrollment: | 60 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2008 |
Rationale: Prostate cancer is a frequently observed malignancy in men, especially in elderly men. Besides diagnosis and treatment, also prevention of prostate cancer is an important point of interest to reduce the incidence and mortality of prostate cancer. Selenium is considered to be a promising chemopreventive agent for prostate cancer. Exact mechanisms of chemoprevention by selenium are not fully understood. However, it is expected that selenium (among other effects) directly affects gene expression in the prostate.
Objective: The aim of this study is to get insight into bioavailability of selenium in prostate tissue and changes of gene expression profiles that might be responsible for selenium-induced chemoprevention. To meet this objective, the relationship between dietary selenium intake and changes in gene expression profiles, tissue selenium levels and blood flow in prostate tissue will be examined.
Study design: The present study is designed as a double-blind, randomized and placebo-controlled intervention trial. Blood samples, toenails, questionnaires, MR images and surgical specimens will be collected to examine effects of selenium supplementation.
Study population: The study population will consist of 60 men, diagnosed with prostate cancer and scheduled for radical prostatectomy. Written informed consent will be obtained from each participant.
Intervention: Participants will receive 300 ug selenium / day or a placebo during 5 weeks prior to radical prostatectomy. Selenium will be supplemented in the form of selenized yeast tablets (SelenoPrecise, Pharma Nord).
Main study parameters: Levels of selenium in prostate tissue and changes in prostate gene expression profiles of participants supplemented with selenium or placebo, compared before and after the short intervention period, will be considered as the main parameters of the present study. Besides gene expression profiles in prostate tissue, also gene expression profiles of peripheral mononuclear cells (PBMC), levels of selenium in blood and toenails and blood flow and permeability of blood vessels of prostate tissue will be analyzed.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dieuwertje EG Kok, Msc | +31 317 485 901 | dieuwertje.kok@wur.nl |
Contact: Lydia Afman, PhD | +31 317 485 789 | lydia.afman@wur.nl |
Netherlands, Gelderland | |
University Medical Center St Radboud | Recruiting |
Nijmegen, Gelderland, Netherlands, 6500 HB | |
Contact: Dieuwertje EG Kok, MSc +31 317 585 901 dieuwertje.kok@wur.nl | |
Principal Investigator: Dieuwertje EG Kok, MSc | |
Wageningen University | Not yet recruiting |
Wageningen, Gelderland, Netherlands, 6700 EV | |
Contact: Dieuwertje EG Kok, MSc +31 317 485 901 dieuwertje.kok@wur.nl |
Study Chair: | J.A. Witjes, Md PhD Prof | University Medical Center St Radboud |
Study Chair: | L.A.L.M. Kiemeney, PhD Prof | University Medical Center St Radboud |
Study Chair: | P. van 't Veer, PhD Prof | Wageningen University |
Study Chair: | L.A. Afman, PhD | Wageningen University |
Study ID Numbers: | WCRF 2004/21, CMO nr. 2007/003, SePros 2006/02, NL14694.091.07 |
Study First Received: | March 12, 2007 |
Last Updated: | June 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00446901 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Prostate Cancer Selenium Chemoprevention Gene expression |
Selenium Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Antioxidants Neoplasms by Site Molecular Mechanisms of Pharmacological Action Growth Substances |
Physiological Effects of Drugs Trace Elements Micronutrients Protective Agents Pharmacologic Actions |