The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer. In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
11
Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a "PET response". Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.
Time frame: Within 3 weeks
The Change in PSA After Zoledronate Therapy
The change in PSA after zoledronate therapy using per cent change.
Time frame: Four weeks after initiating Zoledronate therapy
Change in Bone Scans
Change in bone scans using per cent change in SUVmax.
Time frame: Four weeks after initiating zoledronate therapy
Changes in Bone Turnover Markers
Changes in bone turnover markers using per cent change of BSAP and NTx
Time frame: Four weeks after initiating zoledronte therapy
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