NCT00776594已完成2 期
Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 8
- 主要终点
- Relapse-free Survival
研究概览
简要总结
The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
详细描述
- Participants will be randomized into one of two study groups. The first group will receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will receive ADT alone.
- For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
- Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
- Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •History of biopsy documented prostate cancer (any Gleason score)
- •Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
- •If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
- •PSA recurrence with PSAdt < 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml
- •No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR
- •Prior ADT allowed if < 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
- •ECOG Performance status of 0-1
- •Absolute neutrophil count of >1,500
- •Platelet count > 100,000
- •Hg > 8g/dl
- •No history of bleeding or thromboses within the last 12 months that required medical intervention
排除标准
- •History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
- •Medical condition requiring concomitant corticosteroids
- •Active infection
- •Prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry
- •Documented local recurrence or metastatic prostate cancer
- •Inability to comply with study and/or follow-up procedures
- •Life expectancy of less than 2 years
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
研究组 & 干预措施
Group 2
Experimental
Androgen Deprivation Therapy Alone
干预措施: Androgen Deprivation Therapy (Drug)
Group 1
Experimental
Androgen Deprivation Therapy Plus Bevacizumab
干预措施: Androgen Deprivation Therapy (Drug)
Group 1
Experimental
Androgen Deprivation Therapy Plus Bevacizumab
干预措施: bicalutamide (Drug)
Group 1
Experimental
Androgen Deprivation Therapy Plus Bevacizumab
干预措施: bevacizumab (Drug)
Group 2
Experimental
Androgen Deprivation Therapy Alone
干预措施: bicalutamide (Drug)
结局指标
主要结局
Relapse-free Survival
时间窗: 2 years
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
次要结局
- Number of Participants With PSA <0.2 ng/ml at Six Months(Six months (at completion of treatment))
- Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).(6 months)
- Analysis of Cytokines and Angiogenic Factors in Plasma/Serum(6 months)
研究者
Mary-Ellen Taplin, MD
Associate Professor of Medicine, HMS
Dana-Farber Cancer Institute
研究点 (8)
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