Clinical trial · Interventional
Study of POMELLA™ Extract to Treat Prostate Cancer
Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
NCT01100866CI-TRIAL-00013994terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to slow enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| POMELLA™ (pomegranate extract) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- POMELLA™ 2 x 500mg capsule once daily
- interventionNames
- Dietary Supplement: POMELLA™ (pomegranate extract)
- type
- PLACEBO_COMPARATOR
- label
- Group 2
- description
- POMELLA™ placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Tissue collection and Bioanalysis of the specimens collected
- timeFrame
- Tissue collected on Day 31 (after 30 days of study treatment)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.