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Trial record 20 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT00936975
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Overall
Hide Arm/Group Description Participants on the parent study (“Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer”) receiving 100mg PO QD Dasatinib
Period Title: Overall Study
Started 18
Completed 12
Not Completed 6
Reason Not Completed
Withdrawal by Subject             1
Disease progression             3
Post-Tx scan uninterpretable             2
Arm/Group Title Overall
Hide Arm/Group Description Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
18 participants meeting the eligibility criteria were accrued to the trial and received the baseline PET scan
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
69
(48 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
16
  88.9%
Unknown or Not Reported
2
  11.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
17
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Changes in 18F-fluoride PET (SUV) - Tumor Bone
Hide Description Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans
Arm/Group Title 18F-Fluoride PET
Hide Arm/Group Description:

Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point

fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan

Overall Number of Participants Analyzed 12
Overall Number of Units Analyzed
Type of Units Analyzed: Bone sites
37
Mean (Standard Deviation)
Unit of Measure: SUVmax
-6.67  (8.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 18F-Fluoride PET
Comments This was an exploratory study and no a priori assumptions were employed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -6.6084
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.7644
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
2.Primary Outcome
Title Changes in 18F-fluoride PET SUV - Normal Bone
Hide Description Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of 37 normal bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans
Arm/Group Title 18F-Fluoride PET
Hide Arm/Group Description:

Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point

fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan

Overall Number of Participants Analyzed 12
Overall Number of Units Analyzed
Type of Units Analyzed: Bone sites
37
Mean (Standard Deviation)
Unit of Measure: SUVmax
0.31  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 18F-Fluoride PET
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized Estimating Equation
Comments GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3274
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 18F-Fluoride PET
Comments H0: No difference in uptake b/w normal & tumor bones
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized Estimating Equations
Comments Age was included in the model as a confounder
Method of Estimation Estimation Parameter Slope
Estimated Value 6.98
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.6943
Estimation Comments Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient
3.Primary Outcome
Title Changes in 18F-fluoride Ki - Tumor Bone
Hide Description Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of 37 Tumor bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans
Arm/Group Title 18F-Fluoride PET
Hide Arm/Group Description:

Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point

fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan

Overall Number of Participants Analyzed 12
Overall Number of Units Analyzed
Type of Units Analyzed: Bone sites
37
Mean (Standard Deviation)
Unit of Measure: mL/min/mL
-0.02  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 18F-Fluoride PET
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized Estimating Equations
Comments GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.0177
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0125
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
4.Primary Outcome
Title Changes in 18F-fluoride Ki - Normal Bone
Hide Description Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans
Arm/Group Title 18F-Fluoride PET
Hide Arm/Group Description:

Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point

fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan

Overall Number of Participants Analyzed 12
Overall Number of Units Analyzed
Type of Units Analyzed: Bone sites
37
Mean (Standard Deviation)
Unit of Measure: mL/min/mL
0.0  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 18F-Fluoride PET
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Generalized Estimating Equation
Comments GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.0017
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0027
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 18F-Fluoride PET
Comments H0: influx(Ki) is the same in normal and tumor bones
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1095
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized estimating equations
Comments Age was included in the model as a confounder
Method of Estimation Estimation Parameter Slope
Estimated Value 0.0205
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0128
Estimation Comments Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient
5.Secondary Outcome
Title Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor
Hide Description Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
Participants receiving 100mg PO QD Dasatinib
Overall Number of Participants Analyzed 12
Overall Number of Units Analyzed
Type of Units Analyzed: Bone sites
37
Mean (Standard Deviation)
Unit of Measure: mL/min/mL
-0.01  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1945
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method GEE
Comments GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.
Method of Estimation Estimation Parameter Slope
Estimated Value -0.0115
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0089
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
6.Secondary Outcome
Title Changes in 18F-fluoride Transport (by Patlak Flux) - Normal
Hide Description Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
Participants receiving 100mg PO QD Dasatinib
Overall Number of Participants Analyzed 12
Overall Number of Units Analyzed
Type of Units Analyzed: Bone sites
37
Mean (Standard Deviation)
Unit of Measure: mL/min/mL
0.01  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized Estimating Equations
Comments GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.0061
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0021
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall
Comments H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0670
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized estimating equations
Comments Age was included in the model as a confounder
Method of Estimation Estimation Parameter Slope
Estimated Value 0.0177
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0097
Estimation Comments GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Overall
Comments H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0278
Comments GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.
Method Generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 32.3288
Parameter Dispersion
Type: Standard Error of the mean
Value: 14.6956
Estimation Comments Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient
Time Frame Only AEs that occur within 24 hours (± 4 hours [approximately 10 half lives]) of 18F-fluoride administration will be reported
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall
Hide Arm/Group Description Participants receiving 100mg PO QD Dasatinib
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall
Affected / at Risk (%)
Total   0/18 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Statistician
Organization: ECOG-ACRIN Cancer Research Group
Phone: 401-863-9188
EMail: bherman@stat.brown.edu
Layout table for additonal information
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 ( U.S. NIH Grant/Contract )
U10CA180820 ( U.S. NIH Grant/Contract )
First Submitted: July 9, 2009
First Posted: July 10, 2009
Results First Submitted: February 20, 2015
Results First Posted: July 16, 2015
Last Update Posted: July 16, 2015