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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744549
• Other study ID #: 07-0580-B
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2008
• Last updated: February 13, 2018
• Start date: May 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2018
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• 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:

• 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

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 (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Prostate Cancer Research Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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