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| Sponsors and Collaborators: |
University Health Network, Toronto Prostate Cancer Research Foundation of Canada |
|---|---|
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00744549 |
Purpose
The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of the Prostate Prostate Cancer Prostatic Neoplasms |
Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
|
Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
Twice a day with meals. Lycopene - 20 mg, Vitamin D3 - 200 IU, Selenium - 100 mcg, Green Tea Extract - 75 mg, Vitamin E - 50 IU
Drug: Placebo
Twice a day with meals.
|
|
B: Experimental
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
|
Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
Twice a day with meals. Lycopene - 20 mg, Vitamin D3 - 200 IU, Selenium - 100 mcg, Green Tea Extract - 75 mg, Vitamin E - 50 IU
Drug: Placebo
Twice a day with meals.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Hersey | karen.hersey@uhn.on.ca |
| Canada, Ontario | |
| University Health Network - Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Karen Hersey karen.hersey@uhn.on.ca | |
| Principal Investigator: Neil Fleshner | |
| Principal Investigator: | Neil Fleshner | Princess Margaret Hospital, Canada |
More Information
| Responsible Party: | University Health Network ( Dr. Neil Fleshner ) |
| Study ID Numbers: | 07-0580-B |
| Study First Received: | August 29, 2008 |
| Last Updated: | March 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00744549 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Male Urogenital Diseases Antioxidants Vitamin E |
Vitamin D Lycopene Selenium |
|
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Prostatic Diseases Genital Neoplasms, Male Lycopene Tocopherol Urogenital Neoplasms Bone Density Conservation Agents Tocopherols Selenium Tea Tocotrienol |
Vitamins Tocotrienols Micronutrients Cholecalciferol Tocopherol acetate Trace Elements Genital Diseases, Male Alpha-Tocopherol Vitamin E Vitamin D Vitamin D3 Calciferol Prostatic Neoplasms |
|
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lycopene Physiological Effects of Drugs Urogenital Neoplasms Bone Density Conservation Agents Tocopherols Selenium Neoplasms by Site Therapeutic Uses |
Vitamins Tocotrienols Micronutrients Cholecalciferol Tocopherol acetate Growth Substances Trace Elements Genital Diseases, Male Protective Agents Pharmacologic Actions Alpha-Tocopherol Vitamin E Neoplasms Vitamin D Prostatic Neoplasms |
