Study of POMELLA™ Extract to Treat Prostate Cancer

NCT01100866 | Terminated

• 1 other identifier: PML-01054
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

clinically localized Prostate Cancer; low and intermediate risk for relapse; candidates for radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

POMELLA™ 2 x 500mg capsule once daily

Dietary Supplement: POMELLA™ (pomegranate extract)

Group 2

PLACEBO COMPARATOR

POMELLA™ placebo

Other: Placebo

Interventions

POMELLA™ (pomegranate extract) DIETARY_SUPPLEMENT

in a capsule form, 2 x 500mg once daily

Also known as: POMELLA™

Group 1

Placebo OTHER

placebo capsules

Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Coastal Health: lead
• Lotte & John Hecht Memorial Foundation: collaborator

Study Sites (1)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alan I So, MD, FRCSC

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 9, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

CA (1)