Study of POMELLA™ Extract to Treat Prostate Cancer

This study has been terminated.
(due to slow enrollment)
Sponsor:
Collaborator:
Lotte & John Hecht Memorial Foundation
Information provided by (Responsible Party):
Dr. Alan I. So, Vancouver Coastal Health
ClinicalTrials.gov Identifier:
NCT01100866
First received: April 2, 2010
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Dietary Supplement: POMELLA™ (pomegranate extract)
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery

Resource links provided by NLM:


Further study details as provided by Vancouver Coastal Health:

Primary Outcome Measures:
  • Tissue collection and Bioanalysis of the specimens collected [ Time Frame: Tissue collected on Day 31 (after 30 days of study treatment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: POMELLA™
Placebo Comparator: Group 2
POMELLA™ placebo
Other: Placebo
placebo capsules

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100866

Locations
Canada, British Columbia
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver Coastal Health
Lotte & John Hecht Memorial Foundation
Investigators
Principal Investigator: Alan I So, MD, FRCSC Vancouver Coastal Health
  More Information

No publications provided

Responsible Party: Dr. Alan I. So, Principal Investigator, Vancouver Coastal Health
ClinicalTrials.gov Identifier: NCT01100866     History of Changes
Other Study ID Numbers: PML-01054
Study First Received: April 2, 2010
Last Updated: March 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by Vancouver Coastal Health:
clinically localized Prostate Cancer
low and intermediate risk for relapse
candidates for radical prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014