Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Noni extract
Intervention description: Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of Noni extract in men diagnosed with
      very low risk or low risk prostate cancer
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men with a diagnosis of very low risk (<5% risk of disease relapse after primary
             treatment, criteria; cT1c, Gleason <6, PSA < 10 ng/mL, fewer than 3 positive biopsy
             cores < 50% cancer in any core, PSA density < 0.15 ng/mL/g); low risk (10% risk of
             disease relapse after primary treatment, criteria; cT1-2a, Gleason <6, PSA < 10 ng/mL)
             prostate cancer

          2. Very low risk and low risk groups will be confirmed by Oncotype DX prostate cancer
             test and provided a Genomic Prostate Score (GPS)

          3. 55 years of age and older (>/= 55 years) at the time of informed consent

          4. No evidence of extraprostatic disease on 3T multiparametric pelvic MRI

          5. No baseline PT/PTT abnormalities, coagulopathies, or who are on any blood thinners.

          6. ECOG performance status 0-2

          7. Participants must have normal organ and marrow function as demonstrated by the
             following parameters being:

               -  complete blood count (CBC) - no clinically significant findings

               -  complete metabolic profile (CMP) - no clinically significant findings

          8. Willing to comply with proposed visit and treatment schedule

          9. Able to understand and willing to sign a written informed consent document

        Exclusion Criteria:

          1. Prior history of treated prostate cancer

          2. Concomitant use of medications that are known CYP3A4 substrates

          3. Use of medications or supplements that are known to affect PSA within 30 days prior to
             informed consent, including toremifene citrate, finasteride, testosterone,
             dehydroepiandrosterone (DHEA) or other testosterone-like supplements. No dutasteride
             within 90 days prior to informed consent

          4. Consumption of any concomitant nutritional, herbal supplements, and antioxidants
             should be taken under the discretion of the investigator. The following
             foods/supplements are prohibited at least 7 days prior to initiation of and during
             study treatment:

               -  St. John's wort or hyperforin (potent CYP3A4 enzyme inducer)

               -  Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)

          5. Use of any blood thinners.

          6. Consumption or use of any Noni or Noni-containing products

          7. History of renal or hepatic disease, including history of hepatitis B or C.
             Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or any psychological, familial, sociological or other concomitant
             condition that would not allow adequate compliance with the study protocol

          8. Participation in any other investigational study or use of any other investigational
             agents within 30 days prior to study entry

          9. History of allergic reactions attributed to Noni or other compounds of similar
             chemical or biologic composition to Noni, or the inactive components present in Noni
             capsules.