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

NCT ID: NCT00844792

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer of the Prostate Prostate Cancer Prostatic Neoplasms

Keywords

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Male Urogenital Diseases Antioxidants Vitamin E Vitamin D Lycopene Selenium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.

Group Type EXPERIMENTAL

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

Intervention Type 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

2

This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Twice a day with meals.

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Twice a day with meals.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Fleshner

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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08-0604-CE

Identifier Type: -

Identifier Source: org_study_id