Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer
- 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 >
- 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
- 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
- Patients who are unable to swallow
- Patients with dental cavities that are likely to need dental extraction or root canal
treatment as management