Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
- 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
- Patients who are receiving any other investigational therapy.
- Patients who have received or are receiving any other treatment for their prostate
- 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
- 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.