Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Androgen deprivation therapy free survival.
研究概览
简要总结
Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are conventionally treated with androgen deprivation therapy. However, in patients with limited metastatic load, the time to progression might be. Subsequently, active surveillance of these patients until progression might defer the start of androgen deprivation therapy (ADT) for several months to years. As an alternative, salvage treatment of the limited number of metastases with either surgery or radiotherapy might postpone the start of ADT even longer. The current trial hypothesizes that ADT might be deferred longer following salvage treatment as compared to active surveillance.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of prostate cancer (PCa)
- •Biochemical relapse of PCa following radical local prostate treatment
- •N1 and M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
- •World Health Organization (WHO) performance state 0-1
- •Exclusion of local relapse
- •Age >=18 years old
- •Signed informed consent
排除标准
- •Serum testosterone level <50ng/ml
- •Symptomatic metastases
- •PSA rise while on active treatment with luteinizing hormone-releasing hormone (LHRH)-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen
- •Previous treatment with cytotoxic agent for PCa
- •Treatment during the past month with products known to influence Prostate Specific Antigen (PSA) levels (e.g. fluconazole, finasteride, corticosteroids,...)
- •Disorder precluding understanding of trial information or informed consent
结局指标
主要结局
Androgen deprivation therapy free survival.
时间窗: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.
Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.
次要结局
- Quality of life questionnaire 3(At 3, 6, 9, 12, 15, 18, 21, 24 months)
- Quality of life questionnaire 1.(At 3, 6, 9, 12, 15, 18, 21, 24 months)
- Quality of Life questionnaire 2.(At 3, 6, 9, 12, 15, 18, 21, 24 months)