Clinical trial NCT00936975: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hormone-Resistant Prostate Cancer
Metastatic Malignant Neoplasm in the Bone
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-07-10
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Changes in 18F-fluoride PET (SUV) - Tumor Bone
timeFrame: Baseline and 12 weeks
measure: Changes in 18F-fluoride PET SUV - Normal Bone
timeFrame: Baseline and 12 weeks
measure: Changes in 18F-fluoride Ki - Tumor Bone
timeFrame: Baseline and 12 weeks
measure: Changes in 18F-fluoride Ki - Normal Bone
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor
timeFrame: Baseline and 12 weeks
measure: Changes in 18F-fluoride Transport (by Patlak Flux) - Normal
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: ECOG-ACRIN Cancer Research Group
name: Evan Yu
role: PRINCIPAL_INVESTIGATOR
References: