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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Information provided by:
University Health Network, Toronto Identifier:
First received: February 13, 2009
Last updated: September 19, 2011
Last verified: September 2011
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.

Condition Intervention Phase
Cancer of the Prostate
Prostate Cancer
Prostatic Neoplasms
Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

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. [ 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2008
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.
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
Placebo Comparator: 2
This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.
Drug: Placebo
Twice a day with meals.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00844792

Contact: Karen Hersey Hersey

Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Karen Hersey   
Principal Investigator: Neil Fleshner         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Neil Fleshner Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Neil Fleshner, Univerisity Health Network,Toronto Identifier: NCT00844792     History of Changes
Other Study ID Numbers: 08-0604-CE
Study First Received: February 13, 2009
Last Updated: September 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Male Urogenital Diseases
Vitamin E
Vitamin D

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Vitamin D
Vitamin E
Anticarcinogenic Agents
Antineoplastic Agents
Bone Density Conservation Agents
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Trace Elements processed this record on November 27, 2015