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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00744549
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
The Prostate Cancer Research Foundation of Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744549


Locations
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Canada, Ontario
University Health Network - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
The Prostate Cancer Research Foundation of Canada
Investigators
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Principal Investigator: Neil Fleshner Princess Margaret Hospital, Canada
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00744549    
Other Study ID Numbers: 07-0580-B
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Keywords provided by University Health Network, Toronto:
Male Urogenital Diseases
Antioxidants
Vitamin E
 Vitamin D
Lycopene
Selenium
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Vitamin D
Cholecalciferol
Vitamins
Vitamin E
Selenium
Lycopene
 Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements
Anti-Inflammatory Agents
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents