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

Primary Purpose

Hormone-Resistant Prostate Cancer, Metastatic Malignant Neoplasm in the Bone, Recurrent Prostate Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluorine F 18 Sodium Fluoride
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hormone-Resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be able to provide a written informed consent
  • Men 18 years or older with metastatic castration-resistant prostate cancer enrolling onto the Febbo clinical trial with dasatinib therapy (must meet all inclusion criteria for dasatinib treatment study and comply with requirements of that specific clinical trial)
  • Histologic confirmation of original prostate cancer diagnosis
  • Presence of at least one convincing bone metastasis as defined by bone scintigraphy, computed tomography (CT) scan (magnetic resonance imaging [MRI] if indicated), or plain X-ray
  • Must currently have castrate testosterone levels (< 50 ng/dL) from orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist

Exclusion Criteria:

  • On the nilutamide-only arm (Arm A of the clinical therapeutic trial)

    • Note: However, if a patient crosses-over from nilutamide at the time of progression to add dasatinib therapy, he may be eligible for 18F-fluoride PET imaging protocol if he meets all inclusion criteria for this 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)

Sites / Locations

  • Dana-Farber Cancer Institute
  • Duke University Medical Center
  • Oregon Health and Science University
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-Fluoride PET

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 9, 2009
Last Updated
June 22, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00936975
Brief Title
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases
Official Title
A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone-Resistant Prostate Cancer, Metastatic Malignant Neoplasm in the Bone, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-Fluoride PET
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Fluorine F 18 Sodium Fluoride
Other Intervention Name(s)
18 F-NaF, F-18 NaF
Intervention Description
Undergo fluorine F 18 sodium fluoride PET scan
Primary Outcome Measure Information:
Title
Changes in 18F-fluoride PET (SUV) - Tumor Bone
Description
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
Time Frame
Baseline and 12 weeks
Title
Changes in 18F-fluoride PET SUV - Normal Bone
Description
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
Time Frame
Baseline and 12 weeks
Title
Changes in 18F-fluoride Ki - Tumor Bone
Description
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
Time Frame
Baseline and 12 weeks
Title
Changes in 18F-fluoride Ki - Normal Bone
Description
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
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes in 18F-fluoride Transport (by Patlak Flux) - Normal
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be able to provide a written informed consent Men 18 years or older with metastatic castration-resistant prostate cancer enrolling onto the Febbo clinical trial with dasatinib therapy (must meet all inclusion criteria for dasatinib treatment study and comply with requirements of that specific clinical trial) Histologic confirmation of original prostate cancer diagnosis Presence of at least one convincing bone metastasis as defined by bone scintigraphy, computed tomography (CT) scan (magnetic resonance imaging [MRI] if indicated), or plain X-ray Must currently have castrate testosterone levels (< 50 ng/dL) from orchiectomy or maintenance on a luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist Exclusion Criteria: On the nilutamide-only arm (Arm A of the clinical therapeutic trial) Note: However, if a patient crosses-over from nilutamide at the time of progression to add dasatinib therapy, he may be eligible for 18F-fluoride PET imaging protocol if he meets all inclusion criteria for this 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Yu
Organizational Affiliation
ECOG-ACRIN Cancer Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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