The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TAK-700.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Undergo NaF F18 PET/CT scan
Undergo 18F NaF PET/CT scan
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values
To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.
Time frame: Baseline and 3 months
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate
Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline.
Time frame: Baseline and 3 months
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values
To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline.
Time frame: Baseline and 3 months
Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700
The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.
Time frame: Up to 12 months
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment
Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline PSA data was gathered at baseline and off treatment.
Time frame: Up to 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Undergo 18F NaF PET/CT scan
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700
This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline.
Time frame: At baseline and 12 weeks
Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival.
Time frame: Approximately 24 months
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)
Baseline compared to 12 weeks. Value at three months minus value at baseline.
Time frame: At baseline and 12 weeks
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles
Change from baseline to one month and three month.
Time frame: At baseline, one month, three months
PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results
Time frame: Baseline, one month, 2 months, 3 months