Trial Outcomes & Findings for Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer (NCT NCT02648919)

Last Updated: 2021-11-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Change from screening and at 12 months or early termination

Results posted on

2021-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Noni 6,000 mg/Day Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from screening and at 12 months or early termination

Outcome measures

Outcome measures
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
Compare Genomic Prostate Score (GPS) in Prostatic Tumors GPS Pt 2 Baseline	34 scores on a scale
Compare Genomic Prostate Score (GPS) in Prostatic Tumors GPS Pt 3 Baseline	17 scores on a scale
Compare Genomic Prostate Score (GPS) in Prostatic Tumors GPS Pt 1 Baseline	37 scores on a scale
Compare Genomic Prostate Score (GPS) in Prostatic Tumors GPS Pt 4 Baseline	36 scores on a scale
Compare Genomic Prostate Score (GPS) in Prostatic Tumors GPS Pt 5 Baseline	38 scores on a scale
Compare Genomic Prostate Score (GPS) in Prostatic Tumors GPS Pt 6 Baseline	39 scores on a scale

PRIMARY outcome

Timeframe: Change from screening and at 12 months or early termination

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.

Outcome measures

Outcome measures
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores pre therapy Pt 1	1 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Core post therapy Pt 1	6 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores pre therapy Pt 2	2 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores post therapy Pt 2	5 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores pre therapy Pt 3	1 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores post therapy Pt 3	3 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores pre therapy Pt 4	1 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores post therapy Pt 4	0 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores pre therapy Pt 5	1 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores post therapy Pt 5	0 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores pre therapy Pt 6	1 positive cores
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer Positive Cores post therapy Pt 6	0 positive cores

SECONDARY outcome

Timeframe: Baseline and 9 months

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.

Outcome measures

Outcome measures
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA Baseline Pt 1	4.4 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA Baseline Pt 2	5.4 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA Baseline Pt 3	7.3 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA Baseline Pt 4	9.7 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA Baseline Pt 5	6.9 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA Baseline Pt 6	7.9 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA 9 Month Pt 1	5.7 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA 9 Month Pt 2	9.6 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA 9 Month Pt 3	10.2 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA 9 Month Pt 4	6.9 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA 9 Month Pt 5	8.1 ng/mL
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels PSA 9 Month Pt 6	7.7 ng/mL

SECONDARY outcome

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

Tolerability of Noni extract in men diagnosed with very low risk or low risk prostate cancer as assessed by CTCAE v4.0

Outcome measures

Outcome measures
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
Frequency of Adverse Events	3 Adverse Events Reported

SECONDARY outcome

Timeframe: Enrollment and 12 months or at early termination

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.

Outcome measures

Outcome measures
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
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. Apoptosis Pre Treatment	12.2 percentage of positive cells Standard Deviation 3.2
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. Proliferation Pre Treatment	1.2 percentage of positive cells Standard Deviation 0.3
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. Apoptosis Post Treatment	10.9 percentage of positive cells Standard Deviation 2.1
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. Proliferation Post Treatment	1.4 percentage of positive cells Standard Deviation 0.4

SECONDARY outcome

Timeframe: Enrollment and 12 months or at early termination

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.

Outcome measures

Outcome measures
Measure	Noni 6,000 mg/Day n=6 Participants Noni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) 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.
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. MVD Pre Treatment	60.5 microvessel/mm^2 Standard Deviation 18.1
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. MVD Post Treatment	41.2 microvessel/mm^2 Standard Deviation 9.5

Adverse Events

Noni 6,000 mg/Day

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Noni 6,000 mg/Day n=6 participants at risk Noni extract 6,000 mg/day (4 capsules, 3 times per day) 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.
Gastrointestinal disorders diarrhea	16.7% 1/6 • Number of events 2 • The incidence and severity of adverse events occurring during the study intervention will be reported. The period of time the subject will be receiving study intervention is 12 months. Participants will have study visits at Months 1, 3, 6, 9, and 12 months and at each time point will be assessed for adverse events. All reported Adverse events were followed until resolution.
Psychiatric disorders depression	16.7% 1/6 • Number of events 1 • The incidence and severity of adverse events occurring during the study intervention will be reported. The period of time the subject will be receiving study intervention is 12 months. Participants will have study visits at Months 1, 3, 6, 9, and 12 months and at each time point will be assessed for adverse events. All reported Adverse events were followed until resolution.

Other adverse events

Adverse event data not reported

Additional Information

Stacy Mercado, IIT/ Education Manager

University of Hawaii Cancer Center

Phone: 8084404561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place