Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer

Phase II Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer

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

Efficacy and safety of Noni extract will be assessed in an estimated sample size of 30 subjects. Efficacy will be measured by the induction of favorable gene expression changes on Oncotype Dx Prostate Cancer Test after 12 months of intervention with Noni extract (6,000 mg/day). Other efficacy endpoints include the incidence of tumor progression after 12 months of intervention with Noni extract and serum PSA doubling time. Safety measurements will include the incidence and severity of adverse events, effects on angiogenesis (CD34), cell proliferation (Ki-67), and apoptosis (TUNEL) in prostate tissue biopsy samples from Month 12

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.