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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms

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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

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