Trial Outcomes & Findings for Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases (NCT NCT00936975)

NCT ID: NCT00936975

Last Updated: 2015-07-16

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2015-07-16

Participant Flow

Participant milestones

Measure	Overall Participants on the parent study ("Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer") receiving 100mg PO QD Dasatinib
Overall Study STARTED	18
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Overall Participants on the parent study ("Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer") receiving 100mg PO QD Dasatinib
Overall Study Withdrawal by Subject	1
Overall Study Disease progression	3
Overall Study Post-Tx scan uninterpretable	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall n=18 Participants Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: 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

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

Outcome measures

Measure	18F-Fluoride PET n=37 Bone sites 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
Changes in 18F-fluoride PET (SUV) - Tumor Bone	-6.67 SUVmax Standard Deviation 8.98

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: 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

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

Outcome measures

Measure	18F-Fluoride PET n=37 Bone sites 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
Changes in 18F-fluoride PET SUV - Normal Bone	0.31 SUVmax Standard Deviation 1.17

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: 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

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

Outcome measures

Measure	18F-Fluoride PET n=37 Bone sites 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
Changes in 18F-fluoride Ki - Tumor Bone	-0.02 mL/min/mL Standard Deviation 0.07

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: 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

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

Outcome measures

Measure	18F-Fluoride PET n=37 Bone sites 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
Changes in 18F-fluoride Ki - Normal Bone	0.0 mL/min/mL Standard Deviation 0.01

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Measure	18F-Fluoride PET n=37 Bone sites 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
Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor	-0.01 mL/min/mL Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Measure	18F-Fluoride PET n=37 Bone sites 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
Changes in 18F-fluoride Transport (by Patlak Flux) - Normal	0.01 mL/min/mL Standard Deviation 0.01

Adverse Events

Overall

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Results Reporting Statistician

ECOG-ACRIN Cancer Research Group

Phone: 401-863-9188

Email: bherman@stat.brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60