Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Condition: PSA Level Less Than or Equal to Fifteen; PSA Level Less Than Ten; Stage I Prostate Cancer AJCC v7; Stage II Prostate Cancer AJCC v7; Stage IIA Prostate Cancer AJCC v7; Stage IIB Prostate Cancer AJCC v7
MeSH terms: Prostatic Neoplasms
Intervention: Laboratory Biomarker Analysis; Pharmacological Study; Placebo; Pomegranate-Extract Pill
Intervention description: Correlative studies; Correlative studies; Given PO; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in
      patients with prostate cancer that is limited to a certain part of the body (localized), who
      have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow
      disease progression in patients with localized prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have had a standard-of-care biopsy within 13 months of the baseline
             study visit and must have been diagnosed with low-grade, clinically localized prostate
             cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70
             years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in
             participants >= 70 years of age); eligible participants will be those men who are able
             and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the
             end of the study

          -  No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate
             cancer during study enrollment is planned (unless participants demonstrate clinical
             evidence of prostate cancer progression such as symptoms, physical exam findings, a
             rapidly increasing PSA, or radiologic findings which confirm disease progression)

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1

          -  White blood cells (WBC) >= 3000/mm^3

          -  Platelets >= 100,000 mm^3

          -  Hemoglobin >= 10 g/dL

          -  Total bilirubin =< 1.5 x upper limit of institutional normal

          -  Alkaline phosphatase =< 1.5 x upper limit of institutional normal

          -  Aspartate aminotransferase (AST) =< 1.5 x upper limit of institutional normal

          -  Alanine aminotransferase (ALT) =< 1.5 x upper limit of institutional normal

          -  Serum creatinine within 1.5 x upper limit of institutional normal

          -  Sodium 135-144 mmol/L (inclusive)

          -  Potassium 3.2-4.8 mmol/L (inclusive)

          -  Participants will be required to use a medically-approved method of birth control or
             abstinence if their sexual partner is of child-bearing potential

          -  Participants must be willing to forego foods, beverages and supplements containing
             pomegranate for the duration of the study

          -  Ability to understand, and the willingness to sign, a written informed consent
             document

        Exclusion Criteria:

          -  Any prior surgery to the prostate within 30 days of baseline procedures; NOTE:
             Biopsies are not considered surgeries

          -  Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years

          -  Prior pelvic radiation for any reason

          -  Participants cannot be taking 5-alpha-reductase inhibitors while on study or within 6
             months of the baseline study visit

          -  Participants may not be taking carbamazepine (tegretol)

          -  Participants may not be receiving any other investigational agents

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to PFE

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Any significant cardiac event(s) within the 12 months prior to registration, such as
             episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable
             angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring
             medication