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

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ClinicalTrials.gov Identifier: NCT00744549
Recruitment Status : Suspended (Study is currently on hold and recruitment may resume in the future)
First Posted : September 1, 2008
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene
U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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
Principal Investigator: Neil Fleshner Princess Margaret Hospital, Canada
More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00744549     History of Changes
Other Study ID Numbers: 07-0580-B
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by University Health Network, Toronto:
Male Urogenital Diseases
Antioxidants
Vitamin E
Vitamin D
Lycopene
Selenium

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