Pilot Study of Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treated With Metastases-directed Stereotactic Body Radiation Therapy (SBRT) With and Without Concomitant Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- immune evaluation
研究概览
简要总结
At the moment there is a lack of data in the setting of oligometastatic PC in particular regarding the interaction between ablative SBRT, ADT and patient's immune system response.
The hypothesis underlying this project consists in the idea that the patient's immunological context, RT and ADT may interact in the context of metastatic PC. Indeed the immune landscape of patients may interfere with the efficacy of SBRT and on the other side RT may modulate the immune response by driving immunotolerance.
Scope of the study will be to investigate the immune modulation after SBRT in:
- patients with diagnosis of oligorecurrence during a treatment-free interval
- patients with oligoprogression or oligopersistance during hormonal therapy
详细描述
Prostate cancer (PC) represents the second most common cancer in men worldwide, managed with surgery or radiotherapy (RT) in case of localized disease.
Advanced PC can metastasize and often presents as an oligometastatic state, defined as an intermediate state between localized and widespread diffused disease. Oligometastatic PC is characterized by the presence of a limited number of metastases, commonly 1 to 5 lesions. Recently, the ESTRO-EORTC collaboration characterized the oligometastatic disease and provided a classification into oligorecurrence, and oligoprogression, considering whether oligometastatic disease is diagnosed during a treatment-free interval or during active systemic therapy.
Most common sites of metastases from PC are bones and lymph nodes. Different studies have been already published for oligometastatic PC patients. Singh et al. reported that a number of metastases limited to 5, developed during follow-up after curative treatment of primary tumor, is significantly associated to a better 5-year survival rate (73% vs 43% of patients with more than 5 metastases).
In case of limited number of metastases, stereotactic body radiation therapy (SBRT) seems to be effective but its role in the management of metastatic PC is still debated, due to the paucity of prospective and randomized trials.
We reported the outcome of 92 oligometastatic PC patients treated with SBRT, reaching 1 and 3 years control of treated lesions in 90.9% (95%CI 81.8 - 95.6) and 85.5% (95%CI 74.4 - 92.0), and a median overall survival of 91.6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 ≥ 18years
- •Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- •Adenocarcinoma of the prostate treated with radical prostatectomy or radical RT
- •Diagnosis of 1 to 3 metachronous metastases to bone or lymph nodes or oligoprogression / oligopersistance during ADT of a maximum of 3 metastases in bone or lymph nodes
- •ECOG performance status of 0 - 1
- •Informed consent.
排除标准
- •Visceral metastases
- •Evidence of spinal cord compression (radiological or clinical)
- •Concurrent malignancy
- •Inability to undergo RT
- •History of inflammatory colitis or other active severe comorbidities
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
- •Life expectancy <6 months
研究组 & 干预措施
Stereotactic body radiation treatment (SBRT)
RT treatment Schedule as for clinical practice: Stereotactic body radiation treatment (SBRT) will be delivered with image guidance (image-guided radiation therapy or IGRT) and in the form of volumetric modulated arc therapy (VMAT).
RT treatment Schedule: SBRT will be delivered in 1 to 6 fractions on bone or lymph node metastases. The dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints.
干预措施: Radiotherapy (Procedure)
Stereotactic body radiation treatment (SBRT)
RT treatment Schedule as for clinical practice: Stereotactic body radiation treatment (SBRT) will be delivered with image guidance (image-guided radiation therapy or IGRT) and in the form of volumetric modulated arc therapy (VMAT).
RT treatment Schedule: SBRT will be delivered in 1 to 6 fractions on bone or lymph node metastases. The dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints.
干预措施: androgen deprivation therapy (ADT) (Drug)
Stereotactic body radiation treatment (SBRT)
RT treatment Schedule as for clinical practice: Stereotactic body radiation treatment (SBRT) will be delivered with image guidance (image-guided radiation therapy or IGRT) and in the form of volumetric modulated arc therapy (VMAT).
RT treatment Schedule: SBRT will be delivered in 1 to 6 fractions on bone or lymph node metastases. The dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints.
干预措施: immune evaluation (Biological)
结局指标
主要结局
immune evaluation
时间窗: from the baseline (before SBRT) to 7 days after the end of radiotherapy treatment
Analysis of the immunitary background performed before SBRT and evaluation of immune modulation after RT treatment. Our panels will include markers of T cell differentiation and activation, including CD25, CD39, PD-1, CTL4, KLRG1, TIM3, TIGIT. In addition we will investigate the phenotype and functional state of myeloid subsets in enrolled patients, comprising neutrophils, monocytes and dendritic cells. To this end, markers such as CD66b, CD24, CD16, MHC-II, LOX1, CD36 and CD62L will be included in our analysis.
次要结局
- Progression free survival(2 years)
- Prostate cancer specific survival (PCSS)(2 years)