Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 主要终点
- Disease-free survival according to PSA-value
研究概览
简要总结
PSA-recurrence prostate carcinoma is associated with two general problems.
- Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
- There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value < 0.5 ng/ml according to german S3 guidelines is based on retrospective data.
These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value >= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
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
- 否
入选标准
- •postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml
- •prior irradiation
- •comprehension of study protocol content and signed informed consent form
- •minimum age 18 years
排除标准
- •primary therapy of prostate carcinoma
- •PSA value >= 1 ng/ml
- •diagnosed distant metastases before randomisation (osseous or systemic)
- •performed PET/CT before randomisation
- •malignant slave tumor
- •potent men that are not willing or are unable to apply consequent contraception
- •ongoing drug- and/or alcohol abuse
- •patients that are not willing or able to cooperate according to protocol
- •patients in care
- •patients that are not able to understand German language
研究组 & 干预措施
delayed radiotherapy
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
干预措施: PET/CT (Device)
delayed radiotherapy
PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
干预措施: Radiotherapy after achievement of PSA marginal value (Radiation)
instant radiotherapy
Instant Radiotherapy according to guidelines
干预措施: Instant Radiotherapy according to guidelines (Radiation)
结局指标
主要结局
Disease-free survival according to PSA-value
时间窗: at the end of follow-up period of 4 years
Subjects in the control arm have an aftertreatment period of 5 years. Follow-up period of intervention arm ends after 3 to 5 years after radiotherapy. Duration depends on the surveillance period until marginal value is reached. This period is subtracted from maximum follow-up period of 5 years.
次要结局
- frequency of PSA-persistence(at the end of therapy , an expected average of 6 weeks)
- frequency of changes in therapeutic strategies by additional diagnostics(at the end of therapy , an expected average of 6 weeks)
- analysis for radiation parameters, restricted to patients of initiating center(at the end of therapy , an expected average of 6 weeks)
- therapy and following costs for patients(time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years)
- overall survival(at the end of therapy , an expected average of 6 weeks)
- quality of life and side effects(time frame of 2 weeks before therapy starts; at the end of therapy , an expected average of 6 weeks; during follow-up each 3 months for the first 2 years, then each 6 months for the rest of follow-up period, an expected average of 2 further years)