Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
Primary Purpose
Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of the Prostate focused on measuring Male Urogenital Diseases, Antioxidants, Vitamin E, Vitamin D, Lycopene, Selenium
Eligibility Criteria
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
Sites / Locations
- University Health Network - Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00744549
First Posted
August 29, 2008
Last Updated
February 13, 2018
Sponsor
University Health Network, Toronto
Collaborators
The Prostate Cancer Research Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT00744549
Brief Title
Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
The Prostate Cancer Research Foundation of Canada
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms
Keywords
Male Urogenital Diseases, Antioxidants, Vitamin E, Vitamin D, Lycopene, Selenium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
Arm Title
B
Arm Type
Experimental
Arm Description
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
Intervention Description
Twice a day with meals. Lycopene - 20 mg, Vitamin D3 - 200 IU, Selenium - 100 mcg, Green Tea Extract - 75 mg, Vitamin E - 50 IU
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice a day with meals.
Primary Outcome Measure Information:
Title
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
Time Frame
At baseline MRI compared to 1-year MRI compared to 2-year MRI
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Fleshner
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network - Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
We'll reach out to this number within 24 hrs