Study of POMELLA™ Extract to Treat Prostate Cancer

NCT ID: NCT01100866

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

POMELLA™ 2 x 500mg capsule once daily

Group Type: ACTIVE_COMPARATOR

POMELLA™ (pomegranate extract)

Intervention Type: DIETARY_SUPPLEMENT

in a capsule form, 2 x 500mg once daily

Group 2

POMELLA™ placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo capsules

Interventions

POMELLA™ (pomegranate extract)

in a capsule form, 2 x 500mg once daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo capsules

Intervention Type: OTHER

Other Intervention Names

POMELLA™

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:

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lotte & John Hecht Memorial Foundation

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Alan I. So

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan I So, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Vancouver Coastal Health

Locations

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

PML-01054

Identifier Type: -

Identifier Source: org_study_id