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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844792
• Other study ID #: 08-0604-CE
• 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
• 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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

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.