PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Histological diagnosis of prostate cancer
Evidence of metastatic disease by radiologic criteria
Bone scan within 4 weeks of starting therapy
Creatinine within 2 weeks of registration, calculated creatinine clearance > 60ml/min.
Minimum life expectancy of 6 months
Willingness to have pre-therapy PET scans performed within 2 weeks after registration and post therapy PET scan performed within 1 week after dose of Zometa (a total of 3 PET scans required)
Calculated creatinine clearance > 50ml/min.
No prior Zoledronate therapy
Patients must have disease progression despite testosterone suppression (level<50ng/ml); progression can be by rising PSA ( at least 2 values at least 2 weeks apart) or by new lesions on scans or progression of existing lesions on CT scan.
No concomitant systemic therapy for metastatic prostate cancer is allowed except LHRH analogue should be continued if necessary to maintain testosterone suppression.
No concomitant radiation therapy
Prior RT is allowed if completed at least 2 weeks prior to registration.
Presence of measurable or evaluable disease
If RT has been administered, disease outside the RT port is required.
Willingness to sign informed consent.
Registration and willingness to sign informed consent for separate PET protocol 2335 that describes the PET scan procedure.
Patients must have good oral hygiene which includes having a recent dental evaluation

Exclusion Criteria

Patients who are unable to swallow
Patients with dental cavities that are likely to need dental extraction or root canal treatment as management

Arm && Interventions

Group	Intervention	Description
Zometa & PET Scans	zoledronate therapy	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.
Zometa & PET Scans	PET Scan	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.

Primary Outcome Measures

Name	Time	Method
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.	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.

Secondary Outcome Measures

Name	Time	Method
The Change in PSA After Zoledronate Therapy	Four weeks after initiating Zoledronate therapy	The change in PSA after zoledronate therapy using per cent change.
Change in Bone Scans	Four weeks after initiating zoledronate therapy	Change in bone scans using per cent change in SUVmax.
Changes in Bone Turnover Markers	Four weeks after initiating zoledronte therapy	Changes in bone turnover markers using per cent change of BSAP and NTx

Locations (2): Barbara Ann Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
🇺🇸
Farmington Hills, Michigan, United States