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

Phase 2

Completed

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

• Registration Number: NCT00844792
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

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Exclusion Criteria

• Previous treatment for prostate cancer
• Current use of finasteride or dutasteride

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E	This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.
2	Placebo	This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

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