Effektivität Und Toxizität Einer Perkutanen Hochdosierten Strahlentherapie Bei Patienten Mit Oligometastasen Eines Kastrationsresistenten Prostatakarzinoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Time to PSA progression
研究概览
简要总结
The purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. The effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. Treatment can be stereotactically hypofractionated or conventionally fractionated.
详细描述
This is a multicentric, randomized, prospective Phase II intervention trial. Efficacy is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml). There is a 2:1 randomization between intervention and observation group. Patients with PSA progression in the observation group are offered a new diagnosis. This should preferably correspond to the initial diagnosis.
Therapy is performed for all patients in the intervention arm using high dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy.
The decision as to which regimen the patient is to be treated according to is made by the treating physician, taking into account in particular the location of the volume to be irradiated in relation to the organs at risk and any previous irradiation.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Indication:
- •Oligometastases (1-5) in castration-resistant prostate carcinoma
- •Inclusion Criteria:
- •Patient with good general condition (WHO 0-1)
- •Histologically confirmed prostate carcinoma
- •After definitive local therapy, e.g. radical prostatectomy or definitive radiotherapy (also after neo-adjuvant hormone therapy, after postoperative radiotherapy).
- •PSA progression under ongoing androgen deprivation (defined as three consecutive increasing PSA values at intervals of > 4 weeks and testosterone in the castration area <50ng/dl or <1.73nmol/)
- •Minimum duration of androgen deprivation 6 months before inclusion in study
- •Present complete staging (max. 6 weeks old), preferably by means of PET hybrid imaging with prostate-specific PET tracer
- •Imaging detection of individual active or progressive metastases (max. 5, depending on location) that are accessible to local ablative radiotherapy (histological confirmation of the metastases is not required)
- •No parallel participation to further clinical therapy trials up to 4 weeks before and after radiation therapy
- •Individual case discussion in an interdisciplinary tumor board
- •Patient's ability to consent and written consent
排除标准
- •Severe concomitant disease that limits further life expectancy to < 5 years according to the physician's assessment.
- •PSA > 20ng/ml, testosterone >50 dl or >1,73nmol/l
- •visceral metastasis (e.g. lung, liver, brain)
- •lack of compliance
- •previous taxane-containing chemotherapy
研究组 & 干预措施
local ablative radiotherapy
The therapy is performed for all patients in the intervention arm using high-dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy.
干预措施: local ablative radiotherapy (Radiation)
Observational group
Effectiveness is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml).
There is a 2:1 randomization between intervention and observation group.
结局指标
主要结局
Time to PSA progression
时间窗: 12 month after randomization
Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)
次要结局
- Number of patients without detection of new lesions(12 month after randomization)
- Number of patients with a limited number of metastases at PSA progression(12 month after randomization)
- Change of PSA doubling time(12 month after randomization)
- Number of patients who have PSA response(12 month after randomization)
- Toxicity (CTCAE 5.0)(3 and 12 month after therapy)
- Time to tumor-specific systemic therapy after intervention(12 month after randomization)
研究者
Tobias Hölscher
Principal Investigator
Technische Universität Dresden