NCT00258765终止2 期
A Phase IIb Randomised Clinical Trial of the Tolerability, Safety and Efficacy of Adjuvant Docetaxel-Zoledronic Acid After Prostatectomy for High-risk Early Prostate Cancer (AD-ZAP).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa
研究概览
简要总结
Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce relapse in such cases. Patients will be randomized to receive the adjuvant combination therapy or no therapy. All patients will be monitored closely for signs of relapse and treated appropriately with conventional salvage therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Radical prostatectomy for prostate cancer within last 2 months.
- •Post-operative Kattan nomogram predicts >25% risk of PSA relapse by 5 years.
- •6-week post-operative serum PSA<0.2ng/mL.
- •Low levels of circulating prostate cancer cells in the blood, detected by PCR amplification of PSA mRNA 6 weeks post-prostatectomy.
排除标准
- •Pre-operative serum PSA level >20ng/ml.
- •Clinical evidence of metastases by 6-week post-operative visit.
- •Prior treatment with either ADT or bisphosphonate therapy.
- •Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- •Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)
- •Other protocol defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
Zoledronic Acid
Experimental
干预措施: Zoledronic Acid (Drug)
Docetaxel
Active Comparator
干预措施: Docetaxel (Drug)
结局指标
主要结局
safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa
时间窗: 6 months after study entry
次要结局
未报告次要终点
研究者
研究点 (1)
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