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

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

  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[1]	3 withdrawn before start of participation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
Overall Participants Analyzed; [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
[1] Age (10-year groupings)
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

  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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  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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee J, Sato MM, Coel MN, Lee KH, Kwee SA. Prediction of PSA Progression in Castration-Resistant Prostate Cancer Based on Treatment-Associated Change in Tumor Burden Quantified by 18F-Fluorocholine PET/CT. J Nucl Med. 2016 Jul;57(7):1058-64. doi: 10.2967/jnumed.115.169177. Epub 2016 Feb 16.

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