Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of men with Grade ≥ 3 adverse events the first year
研究概览
简要总结
A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or older and willing and able to provide informed consent;
- •Stage cT1 ≤ cT3b, Clinical resectable
- •Gleason score ≥ 6
- •≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
- •Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
- •No visceral metastasis
- •Metastases suitable for stereotactic body radiotherapy
- •Non symptomatic bone lesions
- •Eligible for surgery
排除标准
- •Prior curative intended treatment for prostate cancer
- •Prior androgen deprivation therapy (ADT)
- •History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status > 1
- •Evaluated not able to fulfil the study protocol.
- •Contraindications against MRI
研究组 & 干预措施
RARP + SBRT + ADT
Radical prostatectomy + extended pelvic lymph node dissection according to EAU guidelines followed by stereotactic body radiotherapy to osseous lesions with six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
干预措施: RARP (Procedure)
RARP + SBRT + ADT
Radical prostatectomy + extended pelvic lymph node dissection according to EAU guidelines followed by stereotactic body radiotherapy to osseous lesions with six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
干预措施: SBRT (Radiation)
RARP + SBRT + ADT
Radical prostatectomy + extended pelvic lymph node dissection according to EAU guidelines followed by stereotactic body radiotherapy to osseous lesions with six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
干预措施: ADT (Drug)
结局指标
主要结局
Proportion of men with Grade ≥ 3 adverse events the first year
时间窗: 1 year
Proportion of men with Grade ≥ 3 adverse events the first year
次要结局
- Proportion of men achieving prostatic specific antigen (PSA) < 0.1 ng/ml(1 year)
- Feasibility of radical prostatectomy in the oligometastatic setting(1 year)
研究者
Peter Busch Østergren
Principal Investigator
Herlev Hospital