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

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

NCT00844792

08-0604-CE

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

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

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo