PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: zoledronate therapy
* Device: PET Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zometa & PET Scans<br>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<br>* 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.<br>* Other names: Zometa;Device: PET Scan<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 3 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, metastatic, zoledronate, zometa