Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer

University Health Network, Toronto48 enrolled

Overview

The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.

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: * Diagnosis of a Gleason score \> or = to 7 adenocarcinoma of the prostate * At least 30% of one core involved * Radical prostatectomy planned * Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent) * ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy. Exclusion Criteria: * Previous treatment for prostate cancer * Current use of finasteride or dutasteride

Locations (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

To determine the impact of combination Vitamin E, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.

Time frame: Blood samples will be collected prior to intervention and 8 weeks later , prior to surgery. Prostate tissue will be harvested at time of surgery, after the prostate has been removed.

Data from ClinicalTrials.gov

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