PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01205646|
Recruitment Status : Completed
First Posted : September 20, 2010
Results First Posted : June 6, 2014
Last Update Posted : December 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: zoledronate therapy Device: PET Scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2015|
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.
- PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. [ Time Frame: Within 3 weeks ]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 ]Evaluate the change in PSA after zoledronate therapy using per cent change.
- Evaluate Changes in Bone Scans [ Time Frame: Four weeks after initiating zoledronate therapy ]Evaluate changes in bone scans using per cent change in SUVmax.
- Changes in Bone Turnover Markers [ Time Frame: Four weeks after initiating zoledronte therapy ]Changes in bone turnover markers using per cent change of BSAP and NTx
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|