Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University Health Network, Toronto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
Collaborator:
Prostate Cancer Research Foundation of Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00744549
First received: August 29, 2008
Last updated: March 16, 2009
Last verified: March 2009
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Purpose
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.
| 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: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer |
Resource links provided by NLM:
Drug Information available for:
alpha-Tocopherol
Cholecalciferol
Lycopene
Vitamin D
Tocopherol
Selenomethionine
alpha-Tocopherol succinate
Tocopherol acetate
dl-alpha-Tocopherol
Camellia sinensis
U.S. FDA Resources
Further study details as provided by University Health Network, Toronto:
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 [ Time Frame: At baseline MRI compared to 1-year MRI compared to 2-year MRI ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
|
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
Drug: Placebo
Twice a day with meals.
|
|
Experimental: B
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
|
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
Drug: Placebo
Twice a day with meals.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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 ClinicalTrials.gov identifier: NCT00744549
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744549
Contacts
| Contact: Karen Hersey | karen.hersey@uhn.on.ca |
Locations
| Canada, Ontario | |
| University Health Network - Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Karen Hersey karen.hersey@uhn.on.ca | |
| Principal Investigator: Neil Fleshner | |
Sponsors and Collaborators
University Health Network, Toronto
Prostate Cancer Research Foundation of Canada
Investigators
| Principal Investigator: | Neil Fleshner | Princess Margaret Hospital, Canada |
More Information
No publications provided
| Responsible Party: | Dr. Neil Fleshner, University Health Network |
| ClinicalTrials.gov Identifier: | NCT00744549 History of Changes |
| Other Study ID Numbers: | 07-0580-B |
| Study First Received: | August 29, 2008 |
| Last Updated: | March 16, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Male Urogenital Diseases Antioxidants Vitamin E |
Vitamin D Lycopene Selenium |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Alpha-Tocopherol Antioxidants Cholecalciferol Ergocalciferols Lycopene Selenium Tocopherols Tocotrienols |
Vitamin D Vitamin E Vitamins Anticarcinogenic Agents Antineoplastic Agents Bone Density Conservation Agents Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Radiation-Protective Agents Therapeutic Uses Trace Elements |
ClinicalTrials.gov processed this record on February 25, 2015