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

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms; Prostate Cancer; Cancer of the Prostate

Treatments: Drug: Placebo; Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT00744549

07-0580-B

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E

B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Dietary Supplement: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E