Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
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| ClinicalTrials.gov Identifier: NCT00744549 |
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Recruitment Status
:
Completed
First Posted
: September 1, 2008
Last Update Posted
: February 14, 2018
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Sponsor:
University Health Network, Toronto
Collaborator:
The Prostate Cancer Research Foundation of Canada
Information provided by (Responsible Party):
University Health Network, Toronto
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Brief Summary:
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 or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
Drug Information available for:
Lycopene
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
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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.
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Experimental: B
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
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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.
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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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744549
Locations
| Canada, Ontario | |
| University Health Network - Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
Sponsors and Collaborators
University Health Network, Toronto
The Prostate Cancer Research Foundation of Canada
Investigators
| Principal Investigator: | Neil Fleshner | Princess Margaret Hospital, Canada |
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00744549 History of Changes |
| Other Study ID Numbers: |
07-0580-B |
| First Posted: | September 1, 2008 Key Record Dates |
| Last Update Posted: | February 14, 2018 |
| Last Verified: | February 2018 |
Keywords provided by University Health Network, Toronto:
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Male Urogenital Diseases Antioxidants Vitamin E |
Vitamin D Lycopene Selenium |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Vitamins Vitamin D Ergocalciferols Cholecalciferol Vitamin E Tocopherols Tocotrienols |
alpha-Tocopherol Selenium Antioxidants Lycopene Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Molecular Mechanisms of Pharmacological Action Protective Agents Trace Elements Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents |