Overview

This trial is active, not recruiting.

Conditions bone metastases, hormone-resistant prostate cancer, recurrent prostate cancer, stage iv prostate cancer
Treatment fluorine f 18 sodium fluoride
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date September 2009
End date August 2011
Trial size 24 participants
Trial identifier NCT00936975, ACRIN 6687, ACRIN-6687, CDR0000647592, NCI-2010-01292, U01CA080098

Summary

This phase II trial is studying how well fluorine F 18 sodium fluoride PET works in evaluating response to dasatinib in patients with prostate cancer and bone metastases. Diagnostic procedures, such as fluorine F 18 sodium fluoride positron emission tomography (PET), may help doctors predict a patient's response to treatment and help plan the best treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib.
fluorine f 18 sodium fluoride 18 F-NaF
Undergo fluorine F 18 sodium fluoride PET scan

Primary Outcomes

Measure
Changes in regional fluoride incorporation as measured by 18F-fluoride PET (SUV and Ki)
time frame: Baseline and 12 weeks

Secondary Outcomes

Measure
Changes in 18F-fluoride transport (K1)
time frame: Baseline and 12 weeks

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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)
Principal investigator Evan Yu
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).