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

19 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Tissue collection and Bioanalysis of the specimens collected

Outcome Description:

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.

Outcome Time Frame:

Tissue collected on Day 31 (after 30 days of study treatment)

Safety Issue:


Principal Investigator

Alan I So, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vancouver Coastal Health


Canada: Health Canada

Study ID:




Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • clinically localized Prostate Cancer
  • low and intermediate risk for relapse
  • candidates for radical prostatectomy
  • Prostatic Neoplasms