Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by University Health Network, Toronto. Recruitment status was Recruiting

First Received on August 29, 2008. Last Updated on March 16, 2009 History of Changes

Sponsor:	University Health Network, Toronto
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Cancer Prostate Cancer Vitamin D Vitamin E

Drug Information available for: alpha-Tocopherol Cholecalciferol DL-alpha-Tocopherol Vitamin D Vitamin E Tocopherols Selenomethionine Tocotrienol Selenium

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

To determine the impact of combination vitamin E, lycopene, and selenium on MRI detected prostate tumor size and/or tumor blood flow among me on active surveillance [ Time Frame: At baseline MRI compared to 1-year MRI compared to 2-year MRI ] [ Designated as safety issue: No ]

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
Experimental: A 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.
Experimental: B 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

Criteria

Inclusion Criteria:

MRI detectable prostate cancer
PSA less than 15 ng/ml
Gleason score <= 7
Prostate cancer staging T1c or T2a

Exclusion Criteria:

Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E
Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma)
Current use of Proscar or Avodart

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744549

Contacts

Contact: Karen Hersey

karen.hersey@uhn.on.ca

Locations

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

Sponsors and Collaborators

University Health Network, Toronto

Prostate Cancer Research Foundation of Canada

Investigators

Principal Investigator:

Neil Fleshner

Princess Margaret Hospital, Canada

More Information

No publications provided

Responsible Party:	Dr. Neil Fleshner, University Health Network
ClinicalTrials.gov Identifier:	NCT00744549 History of Changes
Other Study ID Numbers:	07-0580-B
Study First Received:	August 29, 2008
Last Updated:	March 16, 2009
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Male Urogenital Diseases
Antioxidants
Vitamin E

Vitamin D
Lycopene
Selenium

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antioxidants
Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Lycopene
Cholecalciferol

Vitamin D
Ergocalciferols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents
Trace Elements
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012