Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00936975
First received: July 9, 2009
Last updated: June 22, 2015
Last verified: December 2014
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Intervention: Radiation: Fluorine F 18 Sodium Fluoride

  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
Overall Participants on the parent study (“Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer”) receiving 100mg PO QD Dasatinib

Participant Flow:   Overall Study
    Overall  
STARTED     18  
COMPLETED     12  
NOT COMPLETED     6  
Withdrawal by Subject                 1  
Disease progression                 3  
Post-Tx scan uninterpretable                 2  



  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.
18 participants meeting the eligibility criteria were accrued to the trial and received the baseline PET scan

Reporting Groups
  Description
Overall Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Median (Full Range)
  69  
  (48 to 86)  
Gender  
[units: participants]
 
Female     0  
Male     18  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     16  
Unknown or Not Reported     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     17  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
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1.  Primary:   Changes in 18F-fluoride PET (SUV) - Tumor Bone   [ Time Frame: Baseline and 12 weeks ]

2.  Primary:   Changes in 18F-fluoride PET SUV - Normal Bone   [ Time Frame: Baseline and 12 weeks ]

3.  Primary:   Changes in 18F-fluoride Ki - Tumor Bone   [ Time Frame: Baseline and 12 weeks ]

4.  Primary:   Changes in 18F-fluoride Ki - Normal Bone   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Changes in 18F-fluoride Transport (by Patlak Flux) - Normal   [ Time Frame: Baseline and 12 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Statistician
Organization: ECOG-ACRIN Cancer Research Group
phone: 401-863-9188
e-mail: bherman@stat.brown.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00936975     History of Changes
Other Study ID Numbers: NCI-2010-01292
NCI-2010-01292 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000647592
ACRIN 6687 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ACRIN-6687 ( Other Identifier: CTEP )
U01CA080098 ( US NIH Grant/Contract Award Number )
U10CA180820 ( US NIH Grant/Contract Award Number )
Study First Received: July 9, 2009
Results First Received: February 20, 2015
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration