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

NCT02648919 | Terminated Phase 2 Results DMC

• 1 other identifier: HUANG-2015-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Compare Genomic Prostate Score (GPS) in Prostatic Tumors

  Exploring gene expression changes on Oncotype DX Genomic Prostate Score (GPS). The Oncotype DX assay is a clinically validated 17-gene genomic assay that provides a genomic prostate score (GPS; scale 0-100) measuring the heterogeneous nature of prostate tumors. A higher score means a higher risk of disease. Unfortunately, Genomic Health was unable to run the assay on 12-month prostate biopsy samples in which active cancer was not identified therefore we only have baseline data.

  Change from screening and at 12 months or early termination

• Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer

  Measure tumor size at screening and compare after 12 months of study participation. Disease progression will be identified by either an increase in Gleason score, increase in positive cores, and/or an increase in tumor volume.

  Change from screening and at 12 months or early termination

Secondary Outcomes (4)

• Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels

  Baseline and 9 months

• Frequency of Adverse Events

  Enrollment, 1, 3, 6, 9, and 12 months, and 7 days post treatment

• Explore the Molecular Pathways Contributing to the Activities Associated With Noni Extract in the Prostate Cancer (e.g. Cell Proliferation, and Apoptosis in Prostate Tissue Biopsy Samples) Via Immunohistochemistry (IHC) Staining.

  Enrollment and 12 months or at early termination

• Explore the Molecular Pathways Contributing to the Activities Associated With Noni Extract in the Prostate Cancer (e.g., Angiogenesis) in Prostate Tissue Biopsy Samples) Via Immunohistochemistry (IHC) Staining.

  Enrollment and 12 months or at early termination

Study Arms (1)

Noni 6,000 mg/day

EXPERIMENTAL

Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner)

Drug: Noni extract

Interventions

Noni extract DRUG

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.

Also known as: Healing Noni

Noni 6,000 mg/day

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Very low risk and low risk groups will be confirmed by Oncotype DX prostate cancer test and provided a Genomic Prostate Score (GPS)
• years of age and older (\>/= 55 years) at the time of informed consent
• No evidence of extraprostatic disease on 3T multiparametric pelvic MRI
• No baseline PT/PTT abnormalities, coagulopathies, or who are on any blood thinners.
• ECOG performance status 0-2
• 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
• Willing to comply with proposed visit and treatment schedule
• Able to understand and willing to sign a written informed consent document

You may not qualify if:

• Prior history of treated prostate cancer
• Concomitant use of medications that are known 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)
• Use of any blood thinners.
• Consumption or use of any Noni or Noni-containing products
• 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
• 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.

Sponsors & Collaborators

• University of Hawaii: lead
• University of Hawaii Cancer Research Center: collaborator

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96734, United States

Location

Related Publications (1)

• Issell BF, Franke A, Fielding RM. Pharmacokinetic study of Noni fruit extract. J Diet Suppl. 2008;5(4):373-82. doi: 10.1080/19390210802519671.

  PMID: 22436097 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Stacy Mercado, IIT/ Education Manager
• Organization: University of Hawaii Cancer Center

smercado@cc.hawaii.edu

8084404561

Study Officials

• Jeffrey Huang, PharmD

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 7, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 26, 2021
• Results First Posted: November 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)