Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy (NaFl PET/CT)

University of Wisconsin (UW)

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging

Study type: Observational

Funder types: Other

Identifiers

NCT01516866

2011-0397 (Other Identifier)

CO11811

A534260 (Other Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is very sensitive for changes in bone. By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.

Full description

The study will look at how repeatable the NaF PET scans are before treatment. Scans will also be performed after standard chemotherapy or hormone-directed treatment. This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy. In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA). This information could be used to develop better ways to measure prostate cancer bone lesions. In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.

Enrollment: 58 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the prostate
• Identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone
• Patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR
• Patients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate

Exclusion criteria

• Concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen
• Patients who have received radiotherapy less than 4 weeks prior to registration.
• Patients who have received prior Strontium-89, Samarium-153, or other radioisotope.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).

Trial design

58 participants in 2 patient groups

Cohort A: Microtubule directed chemotherapy treatment

Description:

Subjects receiving antimicrotubule chemotherapy-based treatment will have NaF PET/CT scans at baseline and again after 8 weeks of starting treatment. A subset of subjects will have a second NaF PET/CT scan at baseline 1-8 days after the first baseline scan.

Treatment:

Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging

Cohort B: AR-directed therapy

Description:

Subjects receiving AR-directed therapy will undergo a baseline NaF PET/CT scan at baseline and again after having been on treatment for 6 weeks and again at 12 weeks. A subset of subjects will also undergo a second baseline NaF PET/CT scan 1-8 days after the first baseline scan.

Treatment:

Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging