Prostate CancerPhase 2NCT00732043
Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer
A Phase 2 study testing pomegranate extract and pomegranate juice in people with Prostate Cancer, run by Roll International Corporation at 1 site in United States.
Trial summary
High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- pomegranate extract and pomegranate juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2015
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No evidence of disease progression while on any of the three GUP-0205 study products (disease progression defined as > 100% increase in serum PSA [with a minimum value of 1.0 ng/mL]).
- Willingness and ability to sign an informed consent document.
- Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
- Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) is acceptable provided the dose has been stable during the course of the GUP-0205- 1 study.
Who cannot join
- Significant concomitant medical or psychiatric condition that, in the opinion of the Principal Investigator, would put the subject at risk or compromise the protocol.
- Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT cannot have a serum testosterone of ≤150 ng/mL at study entry.
- Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
- Subjects unable or unwilling to comply with protocol requirements.
- Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
- Serum PSA >7.0 ng/mL (assessed at termination of the double-blind study; at any PSA level, the subject will be excluded if determined by the Principal Investigator that the subject's continued participation would not be in their best interest).
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- Serum PSA doubling time <13 weeks (assessed at termination of the double-blind study).
- Evidence of metastatic disease on physical examination or on CT or bone scan.
- Use of finasteride, dutasteride at any point since primary therapy or during the study.
- Clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2XULN).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Medicine
Los Angeles, California, 90095-1738
About this study
Official title: A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer
High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.
Read the detailed description
The primary objectives are to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12,24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study. Secondary objectives are to determine the effect of the pomegranate treatment on the change in PSA doubling time from baseline to each 12-month visit, to determine the time to tumor recurrence, to assess the tolerability and toxicity of the pomegranate treatment and to determine the effect of the pomegranate treatment on response rates for positive PSA doubling times and for declining post-treatment PSA levels (negative doubling times).
- Conditions
- Prostate Cancer
- Being tested
- pomegranate extract, pomegranate juice, placebo
- Keywords
- prostate cancer, prostate-specific antigen, PSA, pomegranate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomegranate extractDietary supplement
8 oz per day, 48 months
pomegranate juiceDietary supplement
Also called PomWonderful
8 oz per day, 48 months
placeboDietary supplement
8 oz per day, 48 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: pomegranate extract |
| 2 | Experimental | Not described Receives: Dietary Supplement: pomegranate juice |
| 3 | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.
Measured: 48 months
Secondary outcomes (4)
The mean change in PSA doubling time from baseline to end-of-treatment.
Measured: 48 months
Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.
Measured: 48 months
Overall efficacy responses categorized as Objective Response, Progressive Disease, Stable Disease.
Measured: 48 months
Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roll International Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan J Pantuck, MD, Principal investigator, University of California, Los AngelesArie S Belldegrun, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732043
- Sponsor's protocol ID
- GUP-0205-1XX
- Status last verified
- Mar 2012
- First submitted
- 7 Aug 2008
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48-Month Extension to the Randomized, Double-blind, Placebo-Controlled Study of the Effects of Pomegranate Extract on Rising Prostate-Specific Antigen Levels in Men Following Primary Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00732043
- Acronym / sponsor ID
- GUP-0205-1XX
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate-specific antigen, PSA, pomegranate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Roll International CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 11 Aug 2008 (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.
High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.
Detailed description
The primary objectives are to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12,24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study. Secondary objectives are to determine the effect of the pomegranate treatment on the change in PSA doubling time from baseline to each 12-month visit, to determine the time to tumor recurrence, to assess the tolerability and toxicity of the pomegranate treatment and to determine the effect of the pomegranate treatment on response rates for positive PSA doubling times and for declining post-treatment PSA levels (negative doubling times).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: pomegranate extract |
| 2 | Experimental | Dietary Supplement: pomegranate juice |
| 3 | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No evidence of disease progression while on any of the three GUP-0205 study products (disease progression defined as > 100% increase in serum PSA [with a minimum value of 1.0 ng/mL]).
- Willingness and ability to sign an informed consent document.
- Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
- Use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) is acceptable provided the dose has been stable during the course of the GUP-0205- 1 study.
Key exclusion criteria (10 listed)
- Significant concomitant medical or psychiatric condition that, in the opinion of the Principal Investigator, would put the subject at risk or compromise the protocol.
- Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT cannot have a serum testosterone of ≤150 ng/mL at study entry.
- Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
- Subjects unable or unwilling to comply with protocol requirements.
- Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
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 |
|---|---|---|
| pomegranate extract8 oz per day, 48 months | Dietary supplement | 1 |
| pomegranate juiceAlso: PomWonderful8 oz per day, 48 months | Dietary supplement | 2 |
| placebo8 oz per day, 48 months | Dietary supplement | 3 |
Primary outcome
The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.
Time frame: 48 months
4 secondary outcomes
The mean change in PSA doubling time from baseline to end-of-treatment.
Time frame: 48 months
Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.
Time frame: 48 months
Overall efficacy responses categorized as Objective Response, Progressive Disease, Stable Disease.
Time frame: 48 months
Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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.
Allan J Pantuck, MD principal investigator
University of California, Los Angeles
Arie S Belldegrun, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pomegranate extract and pomegranate juice in people with Prostate Cancer, run by Roll International Corporation at 1 site in United States.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Mar 2012. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
The primary outcome variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months. (time frame: 48 months). 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 16 Mar 2012.