Sodium Flouride (NaF) Positron Emission Tomograpy/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Docetaxel-Based Chemo or AR-directed Therapy - Full Text View

Purpose

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.

Condition	Intervention
Prostate Cancer	Procedure: Sodium Flouride (NaF) Positron Emission Tomograpy/Computed Tomography (PET/CT) imaging

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Nuclear Scans Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Evaluate changes on NaF PET/CT images in response to docetaxel-based chemotherapy or androgen receptor (AR)-directed therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
All subjects will undergo NaF PET/CT scanning at baseline and again either 8 weeks after starting treatment with docetaxel-based treatment (Cohort A) OR at both 6 weeks and 12 weeks after starting AR-directed treatment (Cohort B).
Prostate Specific Antigen (PSA) response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.
Response Evaluation Criteria in Solid Tumors (RECIST) response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Radiographic progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort A: Docetaxel-based treatment Subjects receiving Docetaxel-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 2-5 days after the first baseline scan.	Procedure: Sodium Flouride (NaF) Positron Emission Tomograpy/Computed Tomography (PET/CT) imaging Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a docetaxel-based chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed 7 days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (first 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 2-5 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
Cohort B: AR-directed therapy 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 2-5 days after the first baseline scan.	Procedure: Sodium Flouride (NaF) Positron Emission Tomograpy/Computed Tomography (PET/CT) imaging Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a docetaxel-based chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed 7 days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (first 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 2-5 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).

Arms

Assigned Interventions

Cohort A: Docetaxel-based treatment

Subjects receiving Docetaxel-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 2-5 days after the first baseline scan.

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

Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a docetaxel-based chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed 7 days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (first 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 2-5 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).

Cohort B: AR-directed therapy

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 2-5 days after the first baseline scan.

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

Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a docetaxel-based chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed 7 days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (first 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 2-5 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516866

Contacts

Contact: Cancer Connect

1-800-622-8922

Locations

United States, Wisconsin
University of Wisconsin Carbone Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Glenn Liu, MD
Principal Investigator: Robert Jeraj, Ph.D.

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:	Glenn Liu, MD	University of Wisconsin, Madison
Principal Investigator:	Robert Jeraj, Ph.D.	University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01516866 History of Changes
Other Study ID Numbers:	CO11811
Study First Received:	November 28, 2011
Last Updated:	April 17, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Androgen receptor-directed therapy
NaF PET/CT
docetaxel

Additional relevant MeSH terms:

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

Docetaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013

Sodium Flouride (NaF) Positron Emission Tomograpy/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Docetaxel-Based Chemo or AR-directed Therapy (NaFl PET/CT)