PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

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