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

The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00744549

Enrollment

Registered

2008-09-01

Start date

2008-05-31

Completion date

2013-12-31

Last updated

2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms

Keywords

Male Urogenital Diseases, Antioxidants, Vitamin E, Vitamin D, Lycopene, Selenium

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.

Interventions

DIETARY_SUPPLEMENTLycopene, 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

DRUGPlacebo

Twice a day with meals.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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	At baseline MRI compared to 1-year MRI compared to 2-year MRI

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026