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Recurrent Prostate CancerPhase 2NCT01220817

Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study

A Phase 2 study testing 3 POMx capsules and 1 POMx capsule in people with Recurrent Prostate Cancer, run by POM Wonderful LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Recurrent Prostate Cancer
What is being tested?
3 POMx capsules and 1 POMx capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteUnited States
Study dates
Oct 2007to May 2010
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

  • Subject has histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
  • Subject with a rising PSA post-prostatectomy may consider radiation as an alternative. If subject declines radiation, he may be considered eligible in this setting.
  • Subject has a rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry and defined as:
  • Absolute level of PSA >0.4 ng/mL following surgery.
  • Absolute level of PSA >1.5 ng/mL following radiation or cryotherapy.
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  • Absolute level of PSA >0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.).
  • Absolute level of PSA > nadir + 2 following neoadjuvant hormonal therapy along with external beam radiation.
  • Interim PSA values during the immediate pre-study interval may demonstrate a "fluctuation" including a decline; however, the study baseline PSA must have shown a rise within the pre-study 1 year period.
  • Study baseline PSAs must be determined within 4 weeks of study entry.
  • First postoperative PSA permitted if detectable.
  • Subject is >18 years or age.
  • Subject has life expectancy of greater than 6 months.
  • Subject has ECOG performance status 0, 1 or 2
  • Subject has testosterone level of >150 ng/mL at screening.
  • Subjects has normal organ and marrow function as defined below:
  • leukocytes >3,000/mcL
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin within normal limits except for Gilberts
  • AST(SGOT)/ALT(SGPT) >2.5 X upper limit of normal
  • creatinine > 2.5 upper limit of normal
  • testosterone level >150 ng/mL
  • Subject agrees to abstain from other commercially available pomegranate products while participating in this study.
  • Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose while participating in the study.
  • Subject has signed a written informed consent document and agrees to comply with requirements of the study.

Who cannot join

  • Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology.
  • Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, herbal therapies containing estrogen) for a minimum of 1 year prior to study.
  • Subject has had prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product.
  • Subject has consumed more than two 8 ounce glasses of pomegranate juice per week over the past 2 months.
  • Subject has a known allergy to pomegranate juice or ellagic acid.
  • Subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Safety and Efficacy of POMx in Men With Prostate Cancer: An 18-Month, Randomized, Double-Blind, Dose-Finding Study of the Effects of Two (2) Doses of Pomegranate Juice Extract Capsules (1 or 3 Capsules/Day) on Rising Prostate Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated.

Read the detailed description

The study will be an 18-month, prospective, multi-center, double-blind, dose finding study with subjects who have undergone definitive treatment (surgery, cryotherapy, radiation therapy or brachytherapy) for primary prostate tumor and have had documented rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry.

Being tested
3 POMx capsules, 1 POMx capsule
Keywords
prostate, cancer, psa, psadt, pomegranate, POMx
Medical subject headings
Prostatic Neoplasms, Neoplasms, Salivary Gland Adenoma, Pleomorphic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 POMx capsulesDrug

    3 POMx capsules daily

  • 1 POMx capsuleDrug

    1 POMx capsule daily

Study groups in NCT01220817
Study groupRoleWhat they receive
1 POMx capsuleActive comparator1 POMx capsule daily
Receives: Drug: 1 POMx capsule
3 POMx capsules dailyExperimentalNot described
Receives: Drug: 3 POMx capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate specific antigen doubling time (PSADT)

    All subjects who have a baseline PSA value and at least 1 on study PSA value. The PSADT will be calculated as ln 2 (0.693)/ β (slope of the linear regression fit to ln PSA vs. time in months).

    Measured: PSADT assessed at baseline

Secondary outcomes (2)

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Incidence of adverse events Changes in vital signs

    Measured: Safety and tolerability will be continuously assessed throughout the trial

  2. Objective PSA response

    OR: Decrease of 50% or more in the PSA PD: For subjects who achieved a >50% decline in PSA: An increase in PSA value by 50%. Changes in PSA below 5 ng/dL will not be considered assessable for progression.

    For subjects whose PSA has not decreased by 50%: An increase in PSA value >50% of baseline. The PSA must have risen by at least 5 ng/dL.

    OR any radiographic or symptomatic documentation of metastatic or recurrent disease.

    SD: Does not qualify as objective response or progressive disease.

    Measured: PSA levels will be assessed every 3 months throughout the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study startOct 2007
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01220817
Sponsor's protocol ID
POM 2007-001
Status last verified
Apr 2012
First submitted
8 Oct 2010
Last updated
6 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • Paller CJ, Ye X, Wozniak PJ, Gillespie BK, Sieber PR, Greengold RH, Stockton BR, Hertzman BL, Efros MD, Roper RP, Liker HR, Carducci MA. A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer. Prostate Cancer Prostatic Dis. 2013 Mar;16(1):50-5. doi: 10.1038/pcan.2012.20. Epub 2012 Jun 12.

    PubMed 22689129

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3 POMx capsules and 1 POMx capsule in people with Recurrent Prostate Cancer, run by POM Wonderful LLC 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 26 inclusion and 6 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: finished, as of the sponsor's last update on 6 Apr 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Prostate specific antigen doubling time (PSADT) (time frame: PSADT assessed at baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220817, which also lists 1 linked publication.

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 6 Apr 2012.

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