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NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either Docetaxel-based Chemotherapy or Androgen Receptor (AR)-Directed Therapies


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either Docetaxel-based Chemotherapy or Androgen Receptor (AR)-Directed Therapies


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.


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 docetaxel-based chemotherapy regimen for first-line
treatment of 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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.

Outcome Description:

NaF PET/CT scan will be performed within 7 days prior to starting docetaxel- chemotherapy or hormone-directed therapy (baseline #1). A portion of subjects (first 20 subjects at each site, 60 subjects total) will have a second NaF PET/CT scan performed (baseline #2) within 2-5 days of the initial scan to see if measurements repeated over a short period of time are similar.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Glenn Liu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

CO11811

NCT ID:

NCT01516866

Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Androgen receptor-directed therapy
  • NaF PET/CT
  • docetaxel
  • Prostatic Neoplasms

Name

Location
University of Wisconsin Carbone Cancer Center Madison, Wisconsin  53792-5669