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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01203 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 8021 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies carbon-11 acetate and fluorine F 18 sodium fluoride positron emission tomography (PET) as a biomarker of treatment response in patients with prostate cancer that does not respond to treatment with hormones and has spread to other parts of the body. Carbon-11 acetate and fluorine F 18 sodium fluoride are radioactive drugs that may be useful in evaluating prostate cancer activity in response to treatment. Comparing results of diagnostic procedures such as carbon-11 acetate and fluorine F 18 sodium fluoride PET done before and after therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES:
I. Demonstrate that carbon-11 acetate (11C-acetate) and 18F-fluoride (fluorine F 18 sodium fluoride) PET scans change as a result of treatment for men with metastatic castration-resistant prostate cancer by comparison of pre-treatment and 6-12 week post-treatment images (standardized uptake value [SUV], influx constant [Ki], and rate constant [K1]) with clinical response measures.
SECONDARY OBJECTIVES:
I. Compare results from 11C-acetate and 18F-fluoride PET scanning with the patient's clinical bone scan and determine which predicts clinical response better.
II. Compare changes in 11C-acetate and 18F-fluoride PET with changes in prostate-specific antigen (PSA) level.
III. Compare changes in 11C-acetate and 18F-fluoride PET with changes in urinary N-telopeptide and bone alkaline phosphatase.
IV. Determine if either baseline uptake or change in uptake for 11C-acetate and/or 18F-fluoride PET is correlated with progression-free survival by Prostate Cancer Working Group 2 (PCWG2) criteria (Scher, 2008).
V. Determine if either baseline uptake or change in uptake by 11C-acetate and/or 18F-fluoride PET is correlated with skeletal-related events (SREs) defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia.
VI. Percentage of patients that experience adverse events by Common Terminology Criteria for Adverse Events, version 4.0.
VII. For patients who have tissue/blood biomarkers obtained for other indications, directly compare baseline uptake and change in uptake by 11C-acetate and/or 18F-fluoride PET with those biomarkers.
OUTLINE:
Patients receive carbon-11 acetate intravenously (IV) and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts.
After completion of treatment, patients are followed up every 3 months for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (11C-acetate, 18F-fluoride, PET) | Experimental | Patients receive carbon-11 acetate IV and fluorine F 18 sodium fluoride IV over 1 minute and undergo PET at baseline and at 6-12 weeks after systemic therapy starts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon-11 acetate | Radiation | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in prostate cancer metastases as measured by 11C-acetate and 18F-fluoride PET in response to systemic therapy | Percentage change between pre-treatment and post-therapy measurements will be computed for PET measures. Log transformations will be considered if the rates of change are highly skewed. Additionally, changes in PET measures will be analyzed descriptively by a stem-and-leaf plot. | Baseline to up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response data (response, stable disease or progression) | Molecular imaging measures and clinical measures of treatment response, percentage change in PET derived imaging data will be compared to standard clinical parameters. Association between these two types of data decline will be analyzed using the mid-P adjustment to Fisher's exact test (Lancaster, 1961) to evaluate the potential clinical utility of change in 11C-acetate and 18F-fluoride as a biomarker for response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Yu | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| fluorine F 18 sodium fluoride |
| Radiation |
Given IV |
|
|
| positron emission tomography | Procedure | Undergo 11C-acetate and 18F-fluoride PET |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Up to 5 years |
| Proportion of both 11C-acetate and 18F-fluoride PET scans and 99mTc bone scans in discovering suspicious sites that are later confirmed by standard bone scans | Statistical significance of two proportions will be tested with a two-sample t-test for proportions (or nonparametric alternative). | Up to 5 years |
| Change in PSA parameters | Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in PSA. | Baseline to up to 30 days post-PET |
| Change in urinary N-telopeptide | Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in urinary N-telopeptide. | Baseline to up to 30 days post-PET |
| Change in bone alkaline phosphatase | Spearman rank correlation will be used to examine correlations between PET parameters and continuous variable changes in bone alkaline phosphatase. | Baseline to up to 30 days post-PET |
| Progression-free survival (PFS) using PCWG2 | Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on PCWG2 PFS. | Up to 5 years |
| SRE defined as radiographic pathologic fracture, need for radiation to bone, need for surgery, spinal cord compression or malignant hypercalcemia | Cox proportional hazards model will be used to investigate the predictive value of the differences in pre- and post- treatment measures on time of first SRE. | Up to 5 years |
| 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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| ID | Term |
|---|---|
| C438206 | carbon-11 acetate |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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