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Trial record 32 of 1543 for:    Androgens

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

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.
 
ClinicalTrials.gov Identifier: NCT00928174
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : November 19, 2014
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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 Prostate Cancer
Intervention Drug: IV administration of fluorine-18 fluorocholine followed by PET/CT imaging
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
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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.

Period Title: Overall Study
Started 27
Completed 22 [1]
Not Completed 5
[1]
3 withdrawn before start of participation
Arm/Group Title Single Arm
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
<40 0
40-49 years 0
50-59 years 1
60-69 years 9
70-79 years 4
80-89 years 13
[1]
Measure Description: Age (10-year groupings)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
0
   0.0%
Male
27
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
13
  48.1%
Native Hawaiian or Other Pacific Islander
4
  14.8%
Black or African American
0
   0.0%
White
9
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
Hide Description The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.
Time Frame Concurrent with PET Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measure Data Table reflects data from the 22 subjects completing the current study.
Arm/Group Title Single Arm
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: %PET-positive cases in a given PSA range
PSA > 4 ng/mL (19 cases) 100
PSA 2-4 ng/mL (2 cases) 100
PSA > 0.5 - 2 ng/mL (1 cases) 100
PSA <= 0.5 ng/mL (0 cases) 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description

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.

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/27 (0.00%) 
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 (%)
Total   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sandi Kwee, Principal Investigator
Organization: The Queen's Medical Center
Phone: 808-691-5466
EMail: skwee@queens.org
Layout table for additonal information
Responsible Party: Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT00928174     History of Changes
Other Study ID Numbers: RA-2009-009
R21CA139687 ( U.S. NIH Grant/Contract )
First Submitted: June 24, 2009
First Posted: June 25, 2009
Results First Submitted: October 1, 2014
Results First Posted: November 19, 2014
Last Update Posted: November 11, 2015