- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516866
Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy (NaFl PET/CT)
November 14, 2019 updated by: University of Wisconsin, Madison
NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies
The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET).
NaF is a tracer (dye) that is very sensitive for changes in bone.
By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will look at how repeatable the NaF PET scans are before treatment.
Scans will also be performed after standard chemotherapy or hormone-directed treatment.
This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy.
In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA).
This information could be used to develop better ways to measure prostate cancer bone lesions.
In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Primary care clinic
Description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone
- Patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR
- Patients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate
Exclusion Criteria:
- Concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen
- Patients who have received radiotherapy less than 4 weeks prior to registration.
- Patients who have received prior Strontium-89, Samarium-153, or other radioisotope.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort A: Microtubule directed chemotherapy treatment
Subjects receiving antimicrotubule chemotherapy-based treatment will have NaF PET/CT scans at baseline and again after 8 weeks of starting treatment.
A subset of subjects will have a second NaF PET/CT scan at baseline 1-8 days after the first baseline scan.
|
Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B).
All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy.
A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning.
Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week).
Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
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Cohort B: AR-directed therapy
Subjects receiving AR-directed therapy will undergo a baseline NaF PET/CT scan at baseline and again after having been on treatment for 6 weeks and again at 12 weeks.
A subset of subjects will also undergo a second baseline NaF PET/CT scan 1-8 days after the first baseline scan.
|
Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B).
All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy.
A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning.
Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week).
Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.
Time Frame: 2 years
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NaF PET/CT scan will be performed within 14 days prior to starting chemotherapy (antimicrotubule directed chemotherapy) or hormone-directed therapy (baseline #1).
A portion of subjects (up to 20 subjects at each site, 60 subjects total) will have a second NaF PET/CT scan performed (baseline #2) within 1-8 days of the initial scan to see if measurements repeated over a short period of time are similar.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy.
Time Frame: 2 years
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All subjects will undergo NaF PET/CT scanning at baseline and again either 8 weeks after starting treatment with antimicrotubule chemotherapy based treatment (Cohort A) OR at both 6 weeks and 12 weeks after starting AR-directed treatment (Cohort B).
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2 years
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Prostate Specific Antigen (PSA) response
Time Frame: 2 years
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Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.
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2 years
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Response Evaluation Criteria in Solid Tumors (RECIST) response
Time Frame: 2 years
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2 years
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Radiographic progression free survival
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Jeraj, Ph.D., University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2011
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
November 28, 2011
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Actual)
November 18, 2019
Last Update Submitted That Met QC Criteria
November 14, 2019
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO11811
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- 2011-0397 (Other Identifier: Institutional Review Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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