Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms
Conditions
Keywords
Male Urogenital Diseases, Antioxidants, Vitamin E, Vitamin D, Lycopene, Selenium
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.
Interventions
DIETARY_SUPPLEMENTLycopene, 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
DRUGPlacebo
Twice a day with meals.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Canada
Outcome results
None listed