Prostate CancerPhase 2NCT02648919
Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
A Phase 2 study testing Noni extract in people with Prostate Cancer, run by University of Hawaii at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Noni extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 55 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii Cancer Center
Honolulu, Hawaii, 96734
About this study
Official title: 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
Read the detailed 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
- Conditions
- Prostate Cancer
- Being tested
- Noni extract
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noni extractDrug
Also called Healing Noni
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Noni extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from screening and at 12 months or early termination
Secondary outcomes (4)
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.
Measured: Baseline and 9 months
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
Measured: 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.
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.
Measured: 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.
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.
Measured: Enrollment and 12 months or at early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Jeffrey Huang, PharmD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648919
- Sponsor's protocol ID
- HUANG-2015-1
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2015
- Last updated
- 26 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Issell BF, Franke A, Fielding RM. Pharmacokinetic study of Noni fruit extract. J Diet Suppl. 2008;5(4):373-82. doi: 10.1080/19390210802519671.
PubMed 22436097
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02648919
- Acronym / sponsor ID
- HUANG-2015-1
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- University of Hawaii Cancer Research Center
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 26 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noni 6,000 mg/day | Experimental | Drug: Noni extractNoni extract 6,000 mg/day (4 capsules with breakfast, 4 capsules with lunch and 4 capsules with dinner) |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
- 55 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.
Key exclusion criteria (11 listed)
- 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:
- Use of any blood thinners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noni extractAlso: Healing NoniIntervention 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. | Drug | Noni 6,000 mg/day |
Primary outcome
Compare Genomic Prostate Score (GPS) in Prostatic Tumors
Time frame: Change from screening and at 12 months or early termination
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.
Number of Positive Cores Associated With Participants Disease Progression of Prostate Cancer
Time frame: 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.
4 secondary outcomes
Effects of Noni Extract on Serum Prostate Specific Antigen (PSA) Levels
Time frame: Baseline and 9 months
Frequency of Adverse Events
Time frame: 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.
Time frame: 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.
Time frame: Enrollment and 12 months or at early termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22436097Issell BF, Franke A, Fielding RM. Pharmacokinetic study of Noni fruit extract. J Diet Suppl. 2008;5(4):373-82. doi: 10.1080/19390210802519671.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Huang, PharmD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Noni extract in people with Prostate Cancer, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Genomic Prostate Score (GPS) in Prostatic Tumors (time frame: Change from screening and at 12 months or early termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.