Back to resultsPET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
zoledronate therapy
PET Scan
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer, metastatic, zoledronate, zometa
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
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
- Karmanos Cancer Institute Weisberg Cancer Treatment Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zometa & PET Scans
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Change in PSA After Zoledronate Therapy
The change in PSA after zoledronate therapy using per cent change.
Change in Bone Scans
Change in bone scans using per cent change in SUVmax.
Changes in Bone Turnover Markers
Changes in bone turnover markers using per cent change of BSAP and NTx
Full Information
NCT ID
NCT01205646
First Posted
September 17, 2010
Last Updated
April 10, 2019
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01205646
Brief Title
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, metastatic, zoledronate, zometa
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zometa & PET Scans
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
zoledronate therapy
Other Intervention Name(s)
Zometa
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PET Scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
Description
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.
Time Frame
Within 3 weeks
Secondary Outcome Measure Information:
Title
The Change in PSA After Zoledronate Therapy
Description
The change in PSA after zoledronate therapy using per cent change.
Time Frame
Four weeks after initiating Zoledronate therapy
Title
Change in Bone Scans
Description
Change in bone scans using per cent change in SUVmax.
Time Frame
Four weeks after initiating zoledronate therapy
Title
Changes in Bone Turnover Markers
Description
Changes in bone turnover markers using per cent change of BSAP and NTx
Time Frame
Four weeks after initiating zoledronte therapy
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulka N. Vaishampayan, M.D.
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Karmanos Cancer Institute Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
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