Know Cancer

or
forgot password

A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Cancer of the Prostate, Prostate Cancer, Prostatic Neoplasms

Thank you

Trial Information

A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Neil Fleshner

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

08-0604-CE

NCT ID:

NCT00844792

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Cancer of the Prostate
  • Prostate Cancer
  • Prostatic Neoplasms
  • Male Urogenital Diseases
  • Antioxidants
  • Vitamin E
  • Vitamin D
  • Lycopene
  • Selenium
  • Neoplasms
  • Prostatic Neoplasms

Name

Location