Study of POMELLA™ Extract to Treat Prostate Cancer

Vancouver Coastal Health

Status

Terminated

Conditions

Prostate Cancer

Treatments

Dietary Supplement: POMELLA™ (pomegranate extract)

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01100866

PML-01054

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

Male

Ages

19+ years old

Volunteers

No 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.