Study of POMELLA™ Extract to Treat Prostate Cancer

March 10, 2014 updated by: Dr. Alan I. So, Vancouver Coastal Health

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
POMELLA™ 2 x 500mg capsule once daily
Dietary supplement: POMELLA™ (pomegranate extract)
in a capsule form, 2 x 500mg once daily
Other Names:
  • POMELLA™
Placebo Comparator: Group 2
POMELLA™ placebo
Other: Placebo
placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Tissue collected on Day 31 (after 30 days of study treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vancouver Coastal Health

Collaborators

Lotte & John Hecht Memorial Foundation

Investigators

  • Principal Investigator: Alan I So, MD, FRCSC, Vancouver Coastal Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 2, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PML-01054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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