The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Rate of enrolment
研究概览
简要总结
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.
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
- •undetectable PSA (<0.02 ng/ml) within 16 weeks post-operative;
- •≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
排除标准
- •Unwilling to receive ADT;
- •previously received ADT;
- •lymph node metastases
- •allergy to any form of ADT
研究组 & 干预措施
Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
干预措施: Lupron Depot (Drug)
结局指标
主要结局
Rate of enrolment
时间窗: 1 year
Rate (patients/month) of enrolment
次要结局
- Completeness of study assessments(1 year)
- Time to study start-up(1 year)
- Rate of enrolment per site(1 year)
- Proportion of patients completing study intervention per-protocol(1 year)
研究者
Rodney Breau
Dr.
Ottawa Hospital Research Institute