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

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
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Exclusion Criteria:

  • Previous treatment for prostate cancer
  • Current use of finasteride or dutasteride

Sites / Locations

  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2009
Last Updated
October 24, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00844792
Brief Title
Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 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

4. Oversight

Data Monitoring Committee
No

5. 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.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.
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, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.
Time Frame
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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

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

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