Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment sodium fluoride (naf) positron emission tomography/computed tomography (pet/ct) imaging
Sponsor University of Wisconsin, Madison
Start date November 2011
End date October 2017
Trial size 58 participants
Trial identifier NCT01516866, CO11811

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
sodium fluoride (naf) positron emission tomography/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 microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 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).
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.
sodium fluoride (naf) positron emission tomography/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 microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 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).

Primary Outcomes

Measure
The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.
time frame: 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.
time frame: 2 years
Prostate Specific Antigen (PSA) response
time frame: 2 years
Response Evaluation Criteria in Solid Tumors (RECIST) response
time frame: 2 years
Radiographic progression free survival
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

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).

Additional Information

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
Principal investigator Glenn Liu, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.