Study of POMELLA™ Extract to Treat Prostate Cancer

This is a randomized, two-arm, placebo controlled trial to evaluate benefit of treatment using POMELLA™ extract on mechanisms known to drive prostate cancer. This research allows provision for biochemical and histological comparisons to be made between POMELLA™ treated and placebo treated prostate tissues removed from men with organ confined prostate cancer.

• Dietary Supplement: POMELLA™ (pomegranate extract)
  in a capsule form, 2 x 500mg once daily
  Other Name: POMELLA™
• Other: Placebo
  placebo capsules

• Active Comparator: Group 1
  POMELLA™ 2 x 500mg capsule once daily
  Intervention: Dietary Supplement: POMELLA™ (pomegranate extract)
• Placebo Comparator: Group 2
  POMELLA™ placebo
  Intervention: Other: Placebo

Inclusion Criteria:

• Men 18 years or older (19 years in BC) with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by:

  1. Clinical state T1-T2
  2. PSA <20
  3. Gleason score ≤ 7
• ECOG performance status of 0-1.
• Life expectancy greater than 10 years.
• Able to understand and give informed consent.

• Laboratory values must be as follows:

  1. White blood cell count: ≥ 3,000/mm^3
  2. Absolute granulocyte count: ≥ 1,500/mm^3
  3. Platelets: ≥ 100,000/mm^3
  4. Hemoglobin: ≥ 12g/dL
  5. Serum creatinine: ≤ 1.5 x ULN
  6. AST: ≤ 2 x ULN
  7. ALT: ≤ 2 x ULN
  8. Serum calcium: ≤ ULN
  9. Total bilirubin: ≤ 1.5 x ULN

Exclusion Criteria:

• Patients who are receiving any other investigational therapy.
• Patients who have received or are receiving any other treatment for their prostate cancer.
• Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
• Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
• Histologic evidence of small cell carcinoma of the prostate.
• Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study.
• Patients who are receiving any androgens, estrogens or progestational agents.
• Patients with a known hypersensitivity to pomegranates or composites of the capsules/placebo: hydroxypropyl methylcellulose, silicon dioxide or aerosol.
• Patients who are taking any drugs or natural health products which might impact biochemical tests (some examples include: spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, St. John's wort). A washout period of 30 days prior to commencing the study would be necessary for these compounds if required.
• Patients who have chronic active hepatitis.
• Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.