PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
This trial is active, not recruiting.
|Treatments||zoledronate therapy, pet scan|
|Sponsor||Barbara Ann Karmanos Cancer Institute|
|Collaborator||Department of Defense|
|Start date||September 2010|
|End date||August 2013|
|Trial size||11 participants|
|Trial identifier||NCT01205646, WSU 2006-066|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
time frame: Within 3 weeks
Evaluate the Change in PSA After Zoledronate Therapy
time frame: Four weeks after initiating Zoledronate therapy
Evaluate Changes in Bone Scans
time frame: Four weeks after initiating zoledronate therapy
Changes in Bone Turnover Markers
time frame: Four weeks after initiating zoledronte therapy
Male participants of any age.
- 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
- Patients who are unable to swallow
- Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
|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|
|Principal investigator||Ulka N. Vaishampayan, M.D.|
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