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Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer

This study is currently recruiting participants.
Verified September 2011 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00844792
First received: February 13, 2009
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  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 2

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:

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:
Antioxidants
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
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 June 17, 2013