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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
POM Wonderful LLC
ClinicalTrials.gov Identifier:
NCT01220817
First received: October 8, 2010
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Prostate Cancer
Drug: 3 POMx capsules
Drug: 1 POMx capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:
  • Prostate specific antigen doubling time (PSADT) [ Time Frame: PSADT assessed at baseline ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Safety and tolerability will be continuously assessed throughout the trial ] [ Designated as safety issue: Yes ]
    Incidence of adverse events Changes in vital signs

  • Objective PSA response [ Time Frame: PSA levels will be assessed every 3 months throughout the trial ] [ Designated as safety issue: No ]

    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.



Enrollment: 104
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 POMx capsule
1 POMx capsule daily
Drug: 1 POMx capsule
1 POMx capsule daily
Experimental: 3 POMx capsules daily Drug: 3 POMx capsules
3 POMx capsules daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220817

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
POM Wonderful LLC
Investigators
Principal Investigator: Michael Carducci, MD Sidney Kimmel Cancer Center, Johns Hopkins University
  More Information

No publications provided by POM Wonderful LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: POM Wonderful LLC
ClinicalTrials.gov Identifier: NCT01220817     History of Changes
Other Study ID Numbers: POM 2007-001
Study First Received: October 8, 2010
Last Updated: April 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by POM Wonderful LLC:
prostate
cancer
psa
psadt
pomegranate
POMx

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014