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临床试验/NCT03655886
NCT03655886已完成2 期

Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial

University Hospital, Ghent11 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年8月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
43
试验地点
11
主要终点
Feasibility of randomization between both treatment arms as assessed by the randomized proportion

研究概览

简要总结

According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.

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

入选标准

  • Male ≥18y
  • Histologically proven PC
  • Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy) or PSMA PET-CT
  • ECOG 0-1 (2 if related to local PC symptoms)
  • Eligible for local treatment
  • Written informed consent and able and willing to comply with protocol requirements

排除标准

  • Previous systemic treatment for PC except ADT started within 3 months before randomization
  • Previous radiotherapy to the pelvis interfering with prostate irradiation
  • Previous surgery in the pelvis interfering with radical prostatectomy
  • Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
  • Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
  • Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
  • Psychological disorder intervening with understanding the information or the informed consent

结局指标

主要结局

Feasibility of randomization between both treatment arms as assessed by the randomized proportion

时间窗: 48 months

In this trial we want to assess whether it is feasible to randomize patients into both treatment arms. All patients eligible for inclusion will be reported. The eventual proportion of randomized patients will be evaluated. Reasons for exclusion will be monitored.

次要结局

  • Radiographic progression-free survival(48 months)
  • Clinical progression-free survival(48 months)
  • Quality of life (QLQ-C30 + QLQ-PR25)(48 months)
  • Acute and late toxicity due to local treatment(48 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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