NCT01987999

Brief Summary

The purpose of this study is to confirm the findings of an early study with prostate cancer and to expand our knowledge of treating prostate cancer using F-989.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

November 7, 2013

Last Update Submit

September 18, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Gleason Score

    A Gleason Score is obtained from the results of a transrectal needle biopsy of the prostate.

    1 year

Secondary Outcomes (1)

  • Prostate Specific Antigens (PSA)

    1 year

Study Arms (1)

Acetogenins

EXPERIMENTAL

Acetogenins twice (BID) per day for 12 months

Dietary Supplement: Acetogenins

Interventions

AcetogeninsDIETARY_SUPPLEMENT
Acetogenins

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of prostate cancer
  • Referred to the study by their treating physician

You may not qualify if:

  • \- Any type of treatment before starting study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Acetogenins

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty AlcoholsAlcoholsOrganic ChemicalsAlkanesHydrocarbons, AcyclicHydrocarbonsPolyketidesLactonesFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrocyclic CompoundsPolycyclic CompoundsLipids

Study Officials

  • Steven Osguthorpe, ND

    Optimal Health Research

    PRINCIPAL INVESTIGATOR

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

November 7, 2013

First Posted

November 20, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 20, 2019

Record last verified: 2019-09