Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance

NCT ID: NCT00744549

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Cancer of the Prostate; Prostate Cancer; Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.

Group Type: EXPERIMENTAL

Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Twice a day with meals.

B

This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.

Group Type: EXPERIMENTAL

Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Twice a day with meals.

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Twice a day with meals.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Prostate Cancer Research Foundation of Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Fleshner

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

University Health Network - Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

07-0580-B

Identifier Type: -

Identifier Source: org_study_id