Prostate CancerNCT01100866
Study of POMELLA™ Extract to Treat Prostate Cancer
A study testing POMELLA™ (pomegranate extract) in people with Prostate Cancer, run by Vancouver Coastal Health at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- POMELLA™ (pomegranate extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Serum calcium: ≤ ULN
- Total bilirubin: ≤ 1.5 x ULN
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
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
- Being tested
- POMELLA™ (pomegranate extract), Placebo
- Keywords
- clinically localized Prostate Cancer, low and intermediate risk for relapse, candidates for radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POMELLA™ (pomegranate extract)Dietary supplement
Also called POMELLA™
in a capsule form, 2 x 500mg once daily
PlaceboOther
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | POMELLA™ 2 x 500mg capsule once daily Receives: Dietary Supplement: POMELLA™ (pomegranate extract) |
| Group 2 | Placebo comparator | POMELLA™ placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Tissue collected on Day 31 (after 30 days of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Coastal Health
- Sponsor type
- Other government
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Responsible party
- Principal investigator, Dr. Alan I. So, Vancouver Coastal Health
- Investigators
- Alan I So, MD, FRCSC, Principal investigator, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100866
- Sponsor's protocol ID
- PML-01054
- Status last verified
- Mar 2014
- First submitted
- 2 Apr 2010
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of POMELLA™ Extract in Prostate Cancer Patients Scheduled for Surgery
- ClinicalTrials.gov ID
- NCT01100866
- Acronym / sponsor ID
- PML-01054
- Conditions
- Prostate Cancer
- Keywords
- clinically localized Prostate Cancer, low and intermediate risk for relapse, candidates for radical prostatectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vancouver Coastal HealthOther government
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: POMELLA™ (pomegranate extract)POMELLA™ 2 x 500mg capsule once daily |
| Group 2 | Placebo comparator | Other: PlaceboPOMELLA™ placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POMELLA™ (pomegranate extract)Also: POMELLA™in a capsule form, 2 x 500mg once daily | Dietary supplement | Group 1 |
| Placeboplacebo capsules | Other | Group 2 |
Primary outcome
Tissue collection and Bioanalysis of the specimens collected
Time frame: Tissue collected on Day 31 (after 30 days of study treatment)
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.
Results and safety
The study was stopped early (reason given: due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan I So, MD, FRCSC principal investigator
Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POMELLA™ (pomegranate extract) in people with Prostate Cancer, run by Vancouver Coastal Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue collection and Bioanalysis of the specimens collected (time frame: Tissue collected on Day 31 (after 30 days of study treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.