Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who are unable to swallow
- •Patients with dental cavities that are likely to need dental extraction or root canal treatment as management
研究组 & 干预措施
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.
干预措施: zoledronate therapy (Drug)
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.
干预措施: PET Scan (Device)
结局指标
主要结局
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
时间窗: 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.
次要结局
- The Change in PSA After Zoledronate Therapy(Four weeks after initiating Zoledronate therapy)
- Change in Bone Scans(Four weeks after initiating zoledronate therapy)
- Changes in Bone Turnover Markers(Four weeks after initiating zoledronte therapy)
研究者
Ulka Vaishampayan
Principal Investigator
Barbara Ann Karmanos Cancer Institute