Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GTx |
---|---|
Information provided by: | GTx |
ClinicalTrials.gov Identifier: | NCT00106691 |
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
Condition | Intervention | Phase |
---|---|---|
Preneoplastic Conditions Prostatic Intraepithelial Neoplasia |
Drug: toremifene citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN) |
Enrollment: | 1590 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have adequate bone marrow, liver and renal function:
Exclusion Criteria:
Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.
Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.
Responsible Party: | GTx, Inc ( Robert Boger, MD/Medical Monitor ) |
Study ID Numbers: | G300104 |
Study First Received: | March 29, 2005 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00106691 |
Health Authority: | United States: Food and Drug Administration |
neoplasia chemoprevention cancer premalignant |
precancerous Chemoprophylaxis Intraepithelial Prostatic Neoplasia Neoplasia, Prostatic Intraepithelial |
Prostatic Intraepithelial Neoplasia Prostatic Diseases Genital Neoplasms, Male Precancerous Conditions Carcinoma in Situ Citric Acid |
Urogenital Neoplasms Genital Diseases, Male Toremifene Prostatic Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |