Study of POMELLA™ Extract to Treat Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01100866
• Other study ID #: PML-01054
• Status: Terminated
• Phase: N/A
• First received: April 2, 2010
• Last updated: March 10, 2014
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: March 2014
• Source: Vancouver Coastal Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• POMELLA™ (pomegranate extract)
in a capsule form, 2 x 500mg once daily

Other:
• Placebo
placebo capsules

Locations

Country	Name	City	State
Canada	Vancouver Prostate Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Vancouver Coastal Health	Lotte & John Hecht Memorial Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Tissue collected on Day 31 (after 30 days of study treatment)	No