Noni Extract in Treating Patients with Very Low Risk or Low Risk Prostate Cancer Undergoing Active Surveillance

Inclusion Criteria

• Men with a diagnosis of very low risk (< 5% risk of disease relapse after primary treatment, criteria; cT1c, Gleason =< 6, prostate-specific antigen (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
• Very low risk and low risk groups will be confirmed by Oncotype DX prostate cancer test and provided a genomic prostate score (GPS)
• No evidence of extraprostatic disease on 3T multiparametric pelvic magnetic resonance imaging (MRI)
• No baseline prothrombin time (PT)/partial thromboplastin time (PTT) abnormalities, coagulopathies, or who are on any blood thinners
• Eastern Cooperative Oncology Group (ECOG) performance status 0−2
• Complete blood count (CBC) - no clinically significant findings
• Complete metabolic profile (CMP) - no clinically significant findings
• Lactate dehydrogenase (LDH) - no clinically significant findings
• Willing to comply with proposed visit and treatment schedule
• Able to understand and willing to sign a written informed consent document

Exclusion Criteria

• Prior history of treated prostate cancer
• Concomitant use of medications that are known cytochrome p450 family 3 subfamily A member 4 (CYP3A4) substrates
• 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
• 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)
• Consumption or use of any Noni or Noni-containing products
• History of renal or hepatic disease, including history of hepatitis B or C
• Participation in any other investigational study or use of any other investigational agents within 30 days prior to study entry
• 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; 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