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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02648919
• Other study ID #: HUANG-2015-1
• Status: Terminated
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2021
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Noni extract
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.

Locations

Country	Name	City	State
United States	University of Hawaii Cancer Center	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	University of Hawaii Cancer Research Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels	Comparing the serum Prostate Specific Antigen (PSA) test levels for the duration of the trial in men diagnosed with very low risk or low risk prostate cancer. Measure the duration of time it takes for a subjects Prostate specific antigen level to double.	Baseline and 9 months
Secondary	Frequency of Adverse Events	Tolerability of Noni extract in men diagnosed with very low risk or low risk prostate cancer as assessed by CTCAE v4.0	Enrollment, 1, 3, 6, 9, and 12 months, and 7 days post treatment
Secondary	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.	Utilizing prostate tissue biopsy samples and serum blood plasma from participants prior to receiving noni extract and after the subject completes 12 months of receiving noni extract. Apoptosis was quantified based on caspase-3 immunostaining. Proliferation was quantified based on Ki-67 immunostaining.	Enrollment and 12 months or at early termination
Secondary	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.	Utilizing prostate tissue biopsy samples and serum blood plasma from participants prior to receiving noni extract and after the subject completes 12 months of receiving noni extract. MVD, a surrogate for angiogenesis, was quantified based on CD-31 immunostaining.	Enrollment and 12 months or at early termination