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

NCT00844792 — Phase 2, Completed, 48 participants, University Health Network, Toronto

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A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer

Registry	NCT00844792
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	48 (Actual)
Sponsor	University Health Network, Toronto (Other)
Conditions	Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms
Interventions	Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E, Placebo (Dietary supplement, drug)
Dates	start 2008-10-01, primary completion 2013-12-01, completion 2013-12-01, first posted 2009-02-16, last updated 2017-10-26
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Dietary Supplement: 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 comparator	Drug: Placebo	This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.

Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E (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
Placebo (Drug): Twice a day with meals.

+Outcome measures

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. [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.]

+Eligibility

Sex: Male, ages: 18 Years to any

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)

Facility	City	Country	Status
University Health Network, Princess Margaret Hospital	Toronto, Ontario	Canada

+Investigators

Neil Fleshner, Principal investigator, Princess Margaret Hospital, Canada

My Notes

Public

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