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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00844792

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Prostate Prostate Cancer Prostatic Neoplasms	Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 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 Comparator: 2 This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.	Drug: Placebo Twice a day with meals.

Arm

Intervention/Treatment

Experimental: 1

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

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 Comparator: 2

This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.

Drug: Placebo

Twice a day with meals.

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.