Eradication of Prostate Cancer Using F-989
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetogenins
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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
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
NCT ID
NCT01987999
First Posted
November 7, 2013
Last Updated
September 18, 2019
Sponsor
Optimal Health Research
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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