Carbon-11 Acetate and Fluorine F 18 Sodium Fluoride PET as a Biomarker of Treatment Response in Patients With Hormone Resistant Metastatic Prostate Cancer
PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedAugust 31, 2016
August 1, 2016
2.9 years
June 18, 2014
August 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Clinical response data (response, stable disease or progression)
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
Up to 5 years
Change in PSA parameters
Baseline to up to 30 days post-PET
Change in urinary N-telopeptide
Baseline to up to 30 days post-PET
Change in bone alkaline phosphatase
Baseline to up to 30 days post-PET
- +2 more secondary outcomes
Study Arms (1)
Diagnostic (11C-acetate, 18F-fluoride, PET)
EXPERIMENTALPatients 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.
Interventions
Given IV
Undergo 11C-acetate and 18F-fluoride PET
Eligibility Criteria
You may qualify if:
- Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
- At the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (\< 50 ng/dL) while on continuous androgen deprivation therapy
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
- Be willing and able to comply with scheduled visits and other trial procedures
- Presence of at least one measurable or detectable metastasis as defined by bone scintigraphy, computed tomography (CT) scan appearance (magnetic resonance imaging \[MRI\] if indicated), or plain x-ray appearance
You may not qualify if:
- 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
- Radiation treatment to bone less than 4 weeks from the 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 (G-CSF) within 4 weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
- Inability to lie still for imaging
- Weight \> 300 pounds (lbs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Yu
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 20, 2014
Study Start
December 1, 2015
Primary Completion
November 1, 2018
Last Updated
August 31, 2016
Record last verified: 2016-08