Status:
COMPLETED
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
United States Department of Defense
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
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 establishe...
Eligibility Criteria
Inclusion
- 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
- Patients who are unable to swallow
- Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01205646
Start Date
September 1 2010
End Date
August 1 2015
Last Update
April 12 2019
Active Locations (2)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
2
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334