PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer|
- PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. [ Time Frame: Within 3 weeks ] [ Designated as safety issue: No ]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.
- Evaluate the Change in PSA After Zoledronate Therapy [ Time Frame: Four weeks after initiating Zoledronate therapy ] [ Designated as safety issue: No ]
- Evaluate Changes in Bone Scans [ Time Frame: Four weeks after initiating zoledronate therapy ] [ Designated as safety issue: No ]
- Changes in Bone Turnover Markers [ Time Frame: Four weeks after initiating zoledronte therapy ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Zometa & PET Scans
Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, 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.
Drug: zoledronate therapy
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.
Other Name: ZometaDevice: PET Scan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205646
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Karmanos Cancer Institute Weisberg Cancer Treatment Center|
|Farmington Hills, Michigan, United States, 48334|
|Principal Investigator:||Ulka N. Vaishampayan, M.D.||Barbara Ann Karmanos Cancer Institute|