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Study of POMELLA™ Extract to Treat Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
POMELLA™ (pomegranate extract)
Placebo
Sponsored by
Vancouver Coastal Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring clinically localized Prostate Cancer, low and intermediate risk for relapse, candidates for radical prostatectomy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Vancouver Prostate Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

POMELLA™ 2 x 500mg capsule once daily

POMELLA™ placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2010
Last Updated
March 10, 2014
Sponsor
Vancouver Coastal Health
Collaborators
Lotte & John Hecht Memorial Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01100866
Brief Title
Study of POMELLA™ Extract to Treat Prostate Cancer
Official Title
Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
due to slow enrollment
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vancouver Coastal Health
Collaborators
Lotte & John Hecht Memorial Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
clinically localized Prostate Cancer, low and intermediate risk for relapse, candidates for radical prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
POMELLA™ 2 x 500mg capsule once daily
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
POMELLA™ placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
POMELLA™ (pomegranate extract)
Other Intervention Name(s)
POMELLA™
Intervention Description
in a capsule form, 2 x 500mg once daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo capsules
Primary Outcome Measure Information:
Title
Tissue collection and Bioanalysis of the specimens collected
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.
Time Frame
Tissue collected on Day 31 (after 30 days of study treatment)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan I So, MD, FRCSC
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Prostate Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study of POMELLA™ Extract to Treat Prostate Cancer

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