Stereotactic Radiotherapy for Oligometastatic Prostate Cancer (CROP)
Comprehensive Stereotactic Radiotherapy for Oligometastatic Prostate Cancer: A Phase I/II Study
研究概览
详细说明
Patients will receive androgen deprivation therapy (ADT) for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken, where ADT will not be restarted until the prostate specific antigen (PSA) reaches a minimum of 10-15 ng/mL. Lupron 30 mg IM will be delivered every 4 months when on ADT.
The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. It is very likely that nodal metastases will shrink significantly (often completely) with ADT. In this scenario, the involved nodal regions will be treated to a more modest dose of 25 Gy in 5 fractions (roughly equivalent to a dose of 46 Gy in 23 fractions assuming an α/β value of 1.4). Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established stereotactic radiotherapy (SRT) policies at Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.
During any "off" period of ADT (before the PSA rises above 10-15 ng/mL), comprehensive SRT can be repeated if there are new oligometastases that become visible. One month after initiation comprehensive SRT, patients will be contacted to assess for acute toxicities.
After completion of radiotherapy to all disease sites, patients will be followed every 3-4 months with PSA testing until the development of castrate resistant prostate cancer. At the same time points, late toxicity and quality of life will be collected for a minimum of 2 years. Computed tomography (CT) of the chest/abdo/pelvis +/- magnetic resonance imaging (MRI) of previously irradiated body sites and bone scan will be performed whenever the PSA reaches ≥ 10 ng/mL (prior to re-starting androgen deprivation therapy during intermittent hormone therapy approach), or at a minimum frequency of once per year.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook Odette Cancer Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Able to provide informed consent.
- ECOG performance status 0-1.
- Histologic confirmation of prostate adenocarcinoma.
- Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.
- ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).
- All sites of disease are amenable to stereotactic radiotherapy.
Exclusion Criteria:
- Castrate resistant prostate cancer.
- Evidence of spinal cord compression.
- Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).
- Inability to safely treat all sites of visible disease.
- Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Stereotactic radiotherapy
Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.
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Patients will receive ADT for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken. The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established SRT policies at the Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease
大体时间：cumulative incidence at 2 years
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common terminology criteria for adverse events (CTCAE) version 4.0
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cumulative incidence at 2 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Quality of Life (EORTC QLQ-C30)
大体时间：proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
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proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
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Time to development of castrate resistant prostate cancer
大体时间：through study completion, an average of 2 years
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through study completion, an average of 2 years
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Radiographic local control of irradiated tumours
大体时间：actuarial rate at 2 years
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actuarial rate at 2 years
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Radiographic "distant" control rate
大体时间：actuarial rate at 2 years
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actuarial rate at 2 years
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Overall survival
大体时间：through study completion, an average of 4 years
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through study completion, an average of 4 years
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合作者和调查者
调查人员
- 首席研究员：Patrick Cheung, M.D.、Toronto Sunnybrook Regional Cancer Centre
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
stereotactic radiotherapy的临床试验
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