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Eradication of Prostate Cancer Using F-989

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetogenins
Sponsored by
Optimal Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- Any type of treatment before starting study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Acetogenins

    Arm Description

    Acetogenins twice (BID) per day for 12 months

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Prostate Specific Antigens (PSA)

    Full Information

    First Posted
    November 7, 2013
    Last Updated
    September 18, 2019
    Sponsor
    Optimal Health Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01987999
    Brief Title
    Eradication of Prostate Cancer Using F-989
    Official Title
    Phase II Eradication of Prostate Cancer Using F-989
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Optimal Health Research

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acetogenins
    Arm Type
    Experimental
    Arm Description
    Acetogenins twice (BID) per day for 12 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Acetogenins
    Primary Outcome Measure Information:
    Title
    Gleason Score
    Description
    A Gleason Score is obtained from the results of a transrectal needle biopsy of the prostate.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Prostate Specific Antigens (PSA)
    Time Frame
    1 year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of prostate cancer Referred to the study by their treating physician Exclusion Criteria: - Any type of treatment before starting study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven Osguthorpe, ND
    Organizational Affiliation
    Optimal Health Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Eradication of Prostate Cancer Using F-989

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