Prostate CancerPhase 2NCT01987999
A Nutraceutical Intervention in Patients With Previously Untreated Human Prostate Cancer
A Phase 2 study testing Acetogenins in people with Prostate Cancer, run by Optimal Health Research.
Trial summary
The purpose of this study is to evaluate weather a novel nutraceutical intervention (F-989) can improve prostate-specific antigerm (PSA) levels and Gleason scores in prostate cancer patients who are on active surveillance. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Acetogenins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of prostate cancer (PSA + biopsy)
- Referred to the study by their treating physician
Who cannot join
- Any type of treatment before starting the study
About this study
Official title: Evaluation of a Novel Nutraceutical Intervention (F-989) in Prostate Cancer Patients on Active Surveillance
The purpose of this study is to evaluate weather a novel nutraceutical intervention (F-989) can improve prostate-specific antigerm (PSA) levels and Gleason scores in prostate cancer patients who are on active surveillance.
- Conditions
- Prostate Cancer
- Being tested
- Acetogenins
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetogeninsDietary supplement
A novel, complex nutraceutical (F-989) that includes herbs, enzymes, phytonutrients, vitamins, and minerals.
| Study group | Role | What they receive |
|---|---|---|
| Novel nutraceutical supplement | Experimental | Novel nutraceutical supplement twice daily with meals for 12 months. Receives: Dietary Supplement: Acetogenins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gleason Score
A Gleason Score is obtained from the results of a transrectal needle biopsy of the prostate.
Measured: 6 months and one year.
Secondary outcomes (1)
Prostate Specific Antigens (PSA)
Serum PSA levels were measured by routine blood testing.
Measured: Every two months up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimal Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Osguthorpe, ND, Principal investigator, Optimal Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987999
- Sponsor's protocol ID
- F-9892131
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2013
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Nutraceutical Intervention (F-989) in Prostate Cancer Patients on Active Surveillance
- ClinicalTrials.gov ID
- NCT01987999
- Acronym / sponsor ID
- F-9892131
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Optimal Health ResearchUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
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 weather a novel nutraceutical intervention (F-989) can improve prostate-specific antigerm (PSA) levels and Gleason scores in prostate cancer patients who are on active surveillance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel nutraceutical supplement | Experimental | Dietary Supplement: AcetogeninsNovel nutraceutical supplement twice daily with meals for 12 months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of prostate cancer (PSA + biopsy)
- Referred to the study by their treating physician
Key exclusion criteria (1 listed)
- Any type of treatment before starting the study
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 |
|---|---|---|
| AcetogeninsA novel, complex nutraceutical (F-989) that includes herbs, enzymes, phytonutrients, vitamins, and minerals. | Dietary supplement | Novel nutraceutical supplement |
Primary outcome
Gleason Score
Time frame: 6 months and one year.
A Gleason Score is obtained from the results of a transrectal needle biopsy of the prostate.
1 secondary outcome
Prostate Specific Antigens (PSA)
Time frame: Every two months up to one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Steven Osguthorpe, ND principal investigator
Optimal Health Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetogenins in people with Prostate Cancer, run by Optimal Health Research.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gleason Score (time frame: 6 months and one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.