Clinical trial NCT01100866: Study of POMELLA™ Extract to Treat Prostate Cancer
Official title: Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: clinically localized Prostate Cancer
low and intermediate risk for relapse
candidates for radical prostatectomy
Lead sponsor: Vancouver Coastal Health
Sponsor class: OTHER_GOV
Collaborators: name: Lotte & John Hecht Memorial Foundation
First posted: 2010-04-09
Enrollment: 1
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Tissue collection and Bioanalysis of the specimens collected
timeFrame: Tissue collected on Day 31 (after 30 days of study treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health
name: Alan I So, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: