Prostate Cancer
Conditions
Keywords
prostate cancer, metastatic, zoledronate, zometa
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.
Interventions
DRUGzoledronate therapy
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.
DEVICEPET Scan
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.
Sponsors
United States Department of Defense
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. | Within 3 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Bone Turnover Markers | Four weeks after initiating zoledronte therapy | Changes in bone turnover markers using per cent change of BSAP and NTx |
| The Change in PSA After Zoledronate Therapy | Four weeks after initiating Zoledronate therapy | The change in PSA after zoledronate therapy using per cent change. |
| Change in Bone Scans | Four weeks after initiating zoledronate therapy | Change in bone scans using per cent change in SUVmax. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zometa & PET Scans 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.
zoledronate therapy: 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.
PET Scan: 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. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Zometa & PET Scans |
|---|---|
| Age, Continuous | 64.09 years STANDARD_DEVIATION 4.53 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: Within 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zometa & PET Scans | PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. | .091 Proportion of participants with response |
Secondary
Change in Bone Scans
Change in bone scans using per cent change in SUVmax.
Time frame: Four weeks after initiating zoledronate therapy
Population: Sample population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zometa & PET Scans | Change in Bone Scans | -10.08 percentage of change of SUVmax |
Secondary
Changes in Bone Turnover Markers
Changes in bone turnover markers using per cent change of BSAP and NTx
Time frame: Four weeks after initiating zoledronte therapy
Population: Patients who had both pre-treatment and post-treatment measures of BSAP and NTx.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zometa & PET Scans | Changes in Bone Turnover Markers | BSAP | -1.66 percentage of change in bio-marker |
| Zometa & PET Scans | Changes in Bone Turnover Markers | NTx | -68.18 percentage of change in bio-marker |
Secondary
The Change in PSA After Zoledronate Therapy
The change in PSA after zoledronate therapy using per cent change.
Time frame: Four weeks after initiating Zoledronate therapy
Population: All patients who had their PSA measured both before and after therapy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zometa & PET Scans | The Change in PSA After Zoledronate Therapy | 38.99 percentage of change in PSA |