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

NCT00936975 | Completed Phase 2 Results

• 6 other identifiers: NCI-2010-01292CDR0000647592ACRIN 6687ACRIN-6687U01CA080098U10CA180820
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Malignant Neoplasm in the Bone; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline and 12 weeks

• 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

  Baseline and 12 weeks

• 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

  Baseline and 12 weeks

• 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

  Baseline and 12 weeks

Secondary Outcomes (2)

• Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor

  Baseline and 12 weeks

• Changes in 18F-fluoride Transport (by Patlak Flux) - Normal

  Baseline and 12 weeks

Study Arms (1)

18F-Fluoride PET

EXPERIMENTAL

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

Radiation: Fluorine F 18 Sodium Fluoride

Interventions

Fluorine F 18 Sodium Fluoride RADIATION

Undergo fluorine F 18 sodium fluoride PET scan

Also known as: 18 F-NaF, F-18 NaF

18F-Fluoride PET

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to provide a written informed consent
• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Results Reporting Statistician
• Organization: ECOG-ACRIN Cancer Research Group

bherman@stat.brown.edu

401-863-9188

Study Officials

• Evan Yu

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2014-12

Locations

US (4)