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

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ClinicalTrials.gov Identifier: NCT00928252
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre

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
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Received 18F-fluorocholine PET/CT
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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).

Period Title: Overall Study
Started 45
Completed 42
Not Completed 3
Reason Not Completed
Physician Decision             3
Arm/Group Title Single Arm
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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.

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
42
 100.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
73
(70 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
0
   0.0%
Male
42
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
 100.0%
1.Primary Outcome
Title Metabolically Active Tumor Volume (MATV) Response
Hide Description Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
Time Frame 21 to 98 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Received 18F-fluorocholine PET/CT
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IV fluorine-18 labeled methylcholine before PET/CT

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

Overall Number of Participants Analyzed 42
Measure Type: Count of Participants
Unit of Measure: Participants
20
  47.6%
2.Primary Outcome
Title Time to PSA Progression
Hide Description Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Received 18F-fluorocholine PET/CT
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 42
Mean (Standard Error)
Unit of Measure: days
MATV reduction > or = 30% 194  (13.759)
MATV reduction < 30% 116  (26.929)
3.Primary Outcome
Title Proportional Hazards Regression Analysis of Time to PSA Progression
Hide Description PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.
Time Frame Up to 15 week post-chemotherapy
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Hide Analysis Population Description
Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response.
Arm/Group Title Positive Metabolically Active Tumor Response
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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. Positive Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV).

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
0.246
(0.083 to 0.728)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
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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.

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%) # Events
Total   5/45 (11.11%)    
Cardiac disorders   
Myocardial Ischemia, Diagnosis *  1/45 (2.22%)  1
Infections and infestations   
Cellulitis *  1/45 (2.22%)  1
Severe Influenza *  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders   
Severe Back Pain *  1/45 (2.22%)  1
Renal and urinary disorders   
Obstructive Uropathy *  1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%) # Events
Total   0/45 (0.00%)    
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
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