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

University Health Network, Toronto16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cancer of the Prostate Prostate Cancer Prostatic Neoplasms

Interventions

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

PlaceboDRUG

Twice a day with meals.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network - Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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