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

Phase 2

Completed

• Conditions: Cancer of the Prostate; Prostatic Neoplasms; Prostate Cancer
• Interventions: Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E; Drug: Placebo

• Registration Number: NCT00744549
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study First Posted: 2008-09-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• MRI detectable prostate cancer
• PSA less than 15 ng/ml
• Gleason score <= 7
• Prostate cancer staging T1c or T2a

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E	This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
A	Placebo	This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
B	Placebo	This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
B	Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E	This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.

Primary Outcome Measures

Name	Time	Method
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	At baseline MRI compared to 1-year MRI compared to 2-year MRI

Trial Locations

Locations (1)

University Health Network - Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada