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Completed

NCT Number: NCT00744549

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

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.

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Key information

Conditions

Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network - Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E

Dietary Supplement

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

Drug

Twice a day with meals.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Prostate Cancer Research Foundation of Canada

Registry information

Official study title

The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2008
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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