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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| U10CA180820 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well fluorine F 18 sodium fluoride positron emission tomography (PET) works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride PET, may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES:
I. Determine if changes in regional fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.
SECONDARY OBJECTIVES:
I. Determine if changes in 18F-fluoride transport (K1), an indicator of blood flow, and therefore, an indirect marker of angiogenesis, occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib.
OUTLINE: This is a multicenter study.
Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. PET parameters (SUV, Ki, and Kl) are also analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Fluoride PET | Experimental | Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Dasatinib was administered under a concurrent protocol and was not considered part of the intervention on this protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorine F 18 Sodium Fluoride | Radiation | Undergo fluorine F 18 sodium fluoride PET scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in 18F-fluoride PET (SUV) - Tumor Bone | 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 | Baseline and 12 weeks |
| Changes in 18F-fluoride PET SUV - Normal Bone | 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 | Baseline and 12 weeks |
| Changes in 18F-fluoride Ki - Tumor Bone | 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 | Baseline and 12 weeks |
| Changes in 18F-fluoride Ki - Normal Bone | 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 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor | 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. | Baseline and 12 weeks |
| Changes in 18F-fluoride Transport (by Patlak Flux) - Normal |
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Inclusion Criteria:
Exclusion Criteria:
On the nilutamide-only arm (Arm A of the clinical therapeutic trial)
Any condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent
A serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and imaging studies
Expected lifespan of 12 weeks or less
Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
Initiation of bisphosphonate therapy less than 4 weeks from the first PET scan
Radiation treatment to bone less than 4 weeks from first PET scan
Radiopharmaceutical treatment to bone less than 4 weeks from first PET scan
Treatment with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte CSF (G-CSF) within 4 weeks prior to first PET scan
Inability to lie still for the imaging
Weight > 300 lbs. (due to equipment specifications)
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| Name | Affiliation | Role |
|---|---|---|
| Evan Yu | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Duke University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | Participants on the parent study ("Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer") receiving 100mg PO QD Dasatinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
| Baseline and 12 weeks |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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18 participants meeting the eligibility criteria were accrued to the trial and received the baseline PET scan
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Changes in 18F-fluoride PET (SUV) - Tumor Bone | 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 | 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 | Posted | Mean | Standard Deviation | SUVmax | Baseline and 12 weeks | Bone sites | Participants |
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| Secondary | Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor | 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. | Posted | Mean | Standard Deviation | mL/min/mL | Baseline and 12 weeks | Bone sites | Participants |
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| Primary | Changes in 18F-fluoride PET SUV - Normal Bone | 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 | 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 | Posted | Mean | Standard Deviation | SUVmax | Baseline and 12 weeks | Bone sites | Participants |
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| Primary | Changes in 18F-fluoride Ki - Tumor Bone | 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 | 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 | Posted | Mean | Standard Deviation | mL/min/mL | Baseline and 12 weeks | Bone sites | Participants |
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| Primary | Changes in 18F-fluoride Ki - Normal Bone | 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 | 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 | Posted | Mean | Standard Deviation | mL/min/mL | Baseline and 12 weeks | Bone sites | Participants |
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| Secondary | Changes in 18F-fluoride Transport (by Patlak Flux) - Normal | 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. | Posted | Mean | Standard Deviation | mL/min/mL | Baseline and 12 weeks | Bone sites | Participants |
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Only AEs that occur within 24 hours (± 4 hours [approximately 10 half lives]) of 18F-fluoride administration will be reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | Participants receiving 100mg PO QD Dasatinib | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Statistician | ECOG-ACRIN Cancer Research Group | 401-863-9188 | bherman@stat.brown.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Bone sites |
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| Bone sites |
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| Bone sites |
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