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Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT00928174
First received: June 24, 2009
Last updated: October 13, 2015
Last verified: October 2015
History of Changes
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Prostate Cancer
Intervention: Drug: IV administration of fluorine-18 fluorocholine followed by PET/CT imaging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Single Arm

Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.

IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.

Participant Flow:   Overall Study
    Single Arm  
STARTED     27  
COMPLETED     22 [1]
NOT COMPLETED     5  
[1] 3 withdrawn before start of participation



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Single Arm

Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.

IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
 		  27  
Age, Customized [1]
[units: participants]
 		 
<40     0  
40-49 years     0  
50-59 years     1  
60-69 years     9  
70-79 years     4  
80-89 years     13  
Gender  
[units: participants]
 		 
Female     0  
Male     27  
Race (NIH/OMB)  
[units: participants]
 		 
American Indian or Alaska Native     0  
Asian     13  
Native Hawaiian or Other Pacific Islander     4  
Black or African American     0  
White     9  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 		 
United States     27  
[1] Age (10-year groupings)



  Outcome Measures

1.  Primary:   Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT   [ Time Frame: Concurrent with PET Procedure ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sandi Kwee, Principal Investigator
Organization: The Queen's Medical Center
phone: 808-691-5466
e-mail: skwee@queens.org



Responsible Party: Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT00928174     History of Changes
Other Study ID Numbers: RA-2009-009
R21CA139687 ( US NIH Grant/Contract Award Number )
Study First Received: June 24, 2009
Results First Received: October 1, 2014
Last Updated: October 13, 2015
Health Authority: United States: Food and Drug Administration