Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer

NCT00844792 | Completed Phase 2

• 1 other identifier: 08-0604-CE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.

Conditions

Cancer of the Prostate; Prostate Cancer; Prostatic Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine the impact of combination Vitamin E, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.

  Blood samples will be collected prior to intervention and 8 weeks later , prior to surgery. Prostate tissue will be harvested at time of surgery, after the prostate has been removed.

Study Arms (2)

1

EXPERIMENTAL

This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.

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

2

PLACEBO COMPARATOR

This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.

Drug: Placebo

Interventions

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

1

Placebo DRUG

Twice a day with meals.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a Gleason score \> or = to 7 adenocarcinoma of the prostate
• At least 30% of one core involved
• Radical prostatectomy planned
• Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent)
• ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy.

You may not qualify if:

• Previous treatment for prostate cancer
• Current use of finasteride or dutasteride

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Male Urogenital Diseases

Interventions

Lycopene; Cholecalciferol; Selenium; Tea; Vitamin E

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Chalcogens; Elements; Inorganic Chemicals; Minerals; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Neil Fleshner

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)