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Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928252
First Posted: June 25, 2009
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
Results First Submitted: June 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Hormone Refractory Prostate Cancer
Intervention: Drug: IV fluorine-18 labeled methylcholine before PET/CT

  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
No text entered.

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
Received 18F-fluorocholine PET/CT

18F-fluoromethylcholine IV in conjunction with PET/CT imaging

IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV).


Participant Flow:   Overall Study
    Received 18F-fluorocholine PET/CT
STARTED   45 
COMPLETED   42 
NOT COMPLETED   3 
Physician Decision                3 



  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

18F-fluoromethylcholine IV in conjunction with PET/CT imaging

IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation.


Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      42 100.0% 
Age 
[Units: Years]
Mean (Full Range)
 73 
 (70 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      42 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Metabolically Active Tumor Volume (MATV) Response   [ Time Frame: 21 to 98 days ]

2.  Primary:   Time to PSA Progression   [ Time Frame: 2 years ]

3.  Primary:   Proportional Hazards Regression Analysis of Time to PSA Progression   [ Time Frame: Up to 15 week post-chemotherapy ]


  Serious Adverse Events


  Other Adverse Events


  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, MD, PhD
Organization: The Queen's Medical Center
phone: 8086915466
e-mail: skwee@queens.org



Responsible Party: Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT00928252     History of Changes
Other Study ID Numbers: RA-2008-069
R21CA139687 ( U.S. NIH Grant/Contract )
First Submitted: June 24, 2009
First Posted: June 25, 2009
Results First Submitted: June 19, 2017
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017