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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Bone Metastases, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

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)


PRIMARY OBJECTIVES:

I. Determine if changes in regional fluoride incorporation (SUV and Ki), as measured by
fluorine F 18 sodium fluoride positron emission tomography, occur in both bone metastases
and normal bone as a response to treatment with dasatinib in patients with
castration-resistant prostate cancer and bone metastases.

SECONDARY OBJECTIVES:

I. Determine if changes in fluorine F 18 sodium fluoride transport (Kl) occur in both bone
metastases and normal bone as a response to treatment with dasatinib in these patients.

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.


Inclusion Criteria:



- Histologically confirmed prostate cancer:

- Metastatic disease

- Has ≥ 1 convincing bone metastasis by bone scintigraphy, CT scan/MRI, or
plain x-ray

- Castration-resistant disease

- Castrate testosterone levels (< 50 ng/dL)

- Has undergone prior orchiectomy OR is currently on maintenance luteinizing
hormone-releasing hormone (LHRH) agonist or LHRH antagonist

- Scheduled to receive treatment with dasatinib on the Febbo clinical trial

- Life expectancy > 12 weeks

- Able to lie still for imaging

- Weighs ≤ 300 lbs.

- No condition that would alter mental status and preclude the basic understanding
and/or authorization of informed consent

- No serious underlying condition that would otherwise impair the patient's ability to
receive treatment and undergo imaging studies

- No extremely poor IV access that would preclude the placement of a peripheral IV line
for injection of a radiotracer

- At least 4 weeks since prior initiation of bisphosphonate therapy

- At least 4 weeks since prior radiotherapy to the bone

- At least 4 weeks since prior radiopharmaceutical treatment to the bone

- More than 4 weeks since prior GM-CSF or G-CSF

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Changes in regional fluoride incorporation as measured by 18F-fluoride PET (SUV and Ki)

Outcome Time Frame:

Baseline and 12 weeks

Safety Issue:

No

Principal Investigator

Evan Yu

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Radiology Imaging Network

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2010-01292

NCT ID:

NCT00936975

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Bone Metastases
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

American College of Radiology Imaging Network Philadelphia, Pennsylvania  19103