Study of POMELLA™ Extract to Treat Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: POMELLA™ (pomegranate extract)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: Clinical state T1-T2 PSA <20 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: White blood cell count: ≥ 3,000/mm^3 Absolute granulocyte count: ≥ 1,500/mm^3 Platelets: ≥ 100,000/mm^3 Hemoglobin: ≥ 12g/dL Serum creatinine: ≤ 1.5 x ULN AST: ≤ 2 x ULN ALT: ≤ 2 x ULN Serum calcium: ≤ ULN 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>POMELLA™ 2 x 500mg capsule once daily | Dietary Supplement: POMELLA™ (pomegranate extract)<br>* in a capsule form, 2 x 500mg once daily<br>* Other names: POMELLA™;|
| Placebo Comparator: Group 2<br>POMELLA™ placebo | Other: Placebo<br>* placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue collection and Bioanalysis of the specimens collected | Prostate tissue are collected at radical radical prostatectomy. These specimens are used to explore the effects of treatment on the expression of the proliferation markers, enzymes, hormnes, receptors and cell signaling proteins known to influence prostate cancer progression. | Tissue collected on Day 31 (after 30 days of study treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinically localized Prostate Cancer, low and intermediate risk for relapse, candidates for radical prostatectomy