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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
Sponsor:
Collaborator:
Prostate Cancer Research Foundation of Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00744549
First received: August 29, 2008
Last updated: March 16, 2009
Last verified: March 2009
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Alpha-Tocopherol
Antioxidants
Cholecalciferol
Ergocalciferols
Lycopene
Selenium
Tocopherols
Tocotrienols
Vitamin D
Vitamin E
Vitamins
Anticarcinogenic Agents
Antineoplastic Agents
Bone Density Conservation Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014