Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00744549

Collaborator

The Prostate Cancer Research Foundation of Canada (Other)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.

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 :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.	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.
Experimental: B This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.	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.

Arm

Intervention/Treatment

Experimental: A

This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.

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.

Experimental: B

This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.

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.

Outcome Measures

Primary Outcome Measures

To determine the impact of combination vitamin E, lycopene, and selenium on MRI detected prostate tumor size and/or tumor blood flow among me on active surveillance [At baseline MRI compared to 1-year MRI compared to 2-year MRI]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

MRI detectable prostate cancer
PSA less than 15 ng/ml
Gleason score <= 7
Prostate cancer staging T1c or T2a

Exclusion Criteria:

Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E
Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma)
Current use of Proscar or Avodart