A Phase 2 interventional study of Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E and Placebo in Cancer of the Prostate, Prostate Cancer and Prostatic Neoplasms, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 48 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.
Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.
Drug: Placebo
Twice a day with meals. Lycopene - 20 mg, Vitamin D3 - 200 IU, Selenium - 100 mcg, Green Tea Extract - 75 mg, Vitamin E - 50 IU
Twice a day with meals.
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.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto