Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vancouver Coastal Health
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Tissue collection and Bioanalysis of the specimens collected
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •Gleason score ≤ 7
- •ECOG performance status of 0-
- •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.
Arms & Interventions
Group 1
POMELLA™ 2 x 500mg capsule once daily
Intervention: POMELLA™ (pomegranate extract) (Dietary Supplement)
Group 2
POMELLA™ placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Tissue collection and Bioanalysis of the specimens collected
Time Frame: Tissue collected on Day 31 (after 30 days of study treatment)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Alan I. So
Principal Investigator
Vancouver Coastal Health