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
|Condition or disease||Intervention/treatment||Phase|
|Hormone Refractory Prostate Cancer||Drug: IV fluorine-18 labeled methylcholine before PET/CT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Received 18F-fluorocholine PET/CT
IV fluorine-18 labeled methylcholine before PET/CT
Drug: IV fluorine-18 labeled methylcholine before PET/CT
Intervention at pre-treatment, and at two timepoints post treatment intiation.
Other Name: 18F-fluorocholine PET/CT
- Metabolically Active Tumor Volume (MATV) Response [ Time Frame: 21 to 98 days ]Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
- Time to PSA Progression [ Time Frame: 2 years ]Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
- Proportional Hazards Regression Analysis of Time to PSA Progression [ Time Frame: Up to 15 week post-chemotherapy ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928252
|United States, Hawaii|
|The Queen's Medical Center|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Sandi A Kwee, MD||The Queen's Medical Center|