Clinical trial NCT01516866: 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
Official title: NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Androgen receptor-directed therapy
NaF PET/CT
antimicrotubule directed chemotherapy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy.
timeFrame: 2 years
measure: Prostate Specific Antigen (PSA) response
timeFrame: 2 years
measure: Response Evaluation Criteria in Solid Tumors (RECIST) response
timeFrame: 2 years
measure: Radiographic progression free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Glenn Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Robert Jeraj, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: