Trial Information
The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
At baseline MRI compared to 1-year MRI compared to 2-year MRI
Safety Issue:
No
Principal Investigator
Neil Fleshner
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Health Canada
Study ID:
07-0580-B
NCT ID:
NCT00744549
Start Date:
May 2008
Completion Date:
Related Keywords:
- Cancer of the Prostate
- Prostate Cancer
- Prostatic Neoplasms
- Male Urogenital Diseases
- Antioxidants
- Vitamin E
- Vitamin D
- Lycopene
- Selenium
- Neoplasms
- Prostatic Neoplasms