Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer - Full Text View

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00844792

Purpose

The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.

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: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for 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, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage. [ Time Frame: Blood samples will be collected prior to intervention and 8 weeks later , prior to surgery. Prostate tissue will be harvested at time of surgery, after the prostate has been removed. ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.	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
Placebo Comparator: 2 This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.	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:

Diagnosis of a Gleason score > or = to 7 adenocarcinoma of the prostate
At least 30% of one core involved
Radical prostatectomy planned
Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent)
ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy.

Exclusion Criteria:

Previous treatment for prostate cancer
Current use of finasteride or dutasteride

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844792

Contacts

Contact: Karen Hersey Hersey

karen.hersey@uhn.ca

Locations

Canada, Ontario
University Health Network, Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Karen Hersey karen.hersey@uhn.ca
Principal Investigator: Neil Fleshner

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Neil Fleshner

Princess Margaret Hospital, Canada

More Information

No publications provided

Responsible Party:	Neil Fleshner, Univerisity Health Network,Toronto
ClinicalTrials.gov Identifier:	NCT00844792 History of Changes
Other Study ID Numbers:	08-0604-CE
Study First Received:	February 13, 2009
Last Updated:	September 19, 2011
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