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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00844792
Other study ID # 08-0604-CE
Secondary ID
Status Completed
Phase Phase 2
First received February 13, 2009
Last updated October 24, 2017
Start date October 2008
Est. completion date December 2013

Study information

Verified date October 2017
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
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
Drug:
Placebo
Twice a day with meals.

Locations

Country Name City State
Canada University Health Network, Princess Margaret Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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