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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Recurrent Prostate Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

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

Outcome Measure:

Prostate specific antigen doubling time (PSADT)

Outcome Description:

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).

Outcome Time Frame:

PSADT assessed at baseline

Safety Issue:

No

Principal Investigator

Michael Carducci, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Cancer Center, Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

POM 2007-001

NCT ID:

NCT01220817

Start Date:

October 2007

Completion Date:

May 2010

Related Keywords:

  • Recurrent Prostate Cancer
  • prostate
  • cancer
  • psa
  • psadt
  • pomegranate
  • POMx
  • Prostatic Neoplasms

Name

Location

Johns Hopkins University Baltimore, Maryland  21205