Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Tolerance of salvage SBRT
研究概览
简要总结
The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy.
The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control with other secondary endpoints which include: Biochemical Response, Biochemical Failure-Free Survival, Metastases-Free Survival, Relapse-Free Survial, Local Control, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25).
The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventionally fractionated/moderately hypofractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B).
The study group is planned to include 55 patients.
详细描述
The diagnosis of local recurrence after radiotherapy in patients with prostate cancer is a serious clinical problem. Interventional salvage treatment in the previously irradiated area is difficult with safety issues of special concern. According to the MASTER meta-analysis the effectiveness of various local salvage methods turned out to be comparable in patients with local recurrence after definitive radiotherapy. Stereotactic radiotherapy (SBRT) had the best toxicity profile, so this non-invasive treatment may be a suitable alternative to other methods. A particular problem is local recurrences after post-prostatectomy radiotherapy. The data on SBRT in such setting are even more scarce than in the case of relapses after definitive radiotherapy. Still, they show a low percentage of serious adverse events of grade ≥3 and good treatment tolerance.
Considering the own experience with re-irradiation of patients with prostate cancer, it was decided that re-irradiation should be carried out in the form of focal SBRT. With the objective of enhancing the safety and quality of salvage re-irradiation, and a comprehensive evaluation of the efficacy of this treatment it was determined that it should be implemented as a prospective phase II study- PROSTARE (PROstate cancer STereotActic Reirradiation).
The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in patients with local recurrence after conventionally fractionated/moderately hypofractionated definitive radiotherapy (Group A), ultrahypofractionated definitive SBRT (Group C), or after prostatectomy and postoperative radiotherapy (Group B).
The study will be conducted as a single-centre study. The evaluation of the safety and effectiveness of such treatment could help develop qualification criteria for repeated irradiation. As a consequence, this should allow for the implementation of this form of treatment into radiotherapy protocols and then, in a controlled and safe way, into clinical practice.
The total sample size will comprise 55 patients. The expected recruitment period is 6 years (10 patients per year).
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Local recurrence of prostate cancer after definitive radiotherapy
- •biopsy proven or/and
- •Consistent MRI and PET-PSMA results and PSA growth dynamics
- •Time since primary radiotherapy - at least 2 years
- •Good performance status (ZUBROD 0-1)
- •If the results of the MRI and PET PSMA are inconsistent, and if there is no technical possibility of performing an MRI biopsy, the treatment is acceptable, but repeated imaging (PET or MRI) should be performed to assess the dynamics of the recurrence.
排除标准
- •Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)
- •Tumour volume (GTV) > 14 cc
- •Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
- •Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
- •Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
- •Previous prostate brachytherapy
- •Substantial risk for further urologic interventions (e.g., TURB/TURP)
结局指标
主要结局
Tolerance of salvage SBRT
时间窗: 3 months post-SBRT, 2-years post-SBRT
Assessment of early and late radiation toxicity: Grade ≥ 3 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria
次要结局
- Tolerance of salvage SBRT(3 months post-SBRT, every 6 months post SBRT up to 3-years post-SBRT)
- Biochemical Control(3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT)
- Biochemical Response(3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT)
- Biochemical Failure-Free Survival (BFS)(3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT)
- Metastases-Free Survival(1-year post SBRT, then annually up to 5-years post-SBRT)
- Relapse-Free Survival(1-year post SBRT, then annually up to 5-years post-SBRT)
- Local Control(1-year post SBRT, then annually up to 5-years post-SBRT)
- Overall Surival(3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT)
- Patients' reported Quality of Life(2-years post SBRT, 3-years post SBRT)