OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.
The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).
The above criteria define 'high metastatic volume' disease with the following parameters
- ≥ 4 bone metastases, including at least one outside the spine and pelvis
- Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines).
- •Histological confirmation of disease by prostate biopsies. Absence of neuroendocrine differentiation
- •Low volume of metastatic disease defined according to CHAARTED study criteria (< of 4 bone metastases, absence of visceral metastases)
- •Patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous RT)
- •Patients treated with systemic therapy (ADT as monotherapy or in combination) for less than 6 months prior to enrolment
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients eligible for local treatment of primary malignancy and concomitant systemic therapy
- •Signature of informed consent
排除标准
- •Inability or unwillingness to give written informed consent
- •High volume metastatic disease defined according to CHARTEED criteria
- •ECOG performance status > 1
- •Patients included in other clinical trials
- •Contraindications to hormone/systemic therapy administration
- •Previous treatment of primary tumour (RP, RT or other treatment of primary tumour)
结局指标
主要结局
Overall survival (OS)
时间窗: from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years
Impact of primary tumour treatment in addition to systemic therapy on overall survival (OS) in patients with new-onset oligometastatic prostate neoplasia.
次要结局
- Cancer-specific survival(from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.)
- Radiological progression-free survival(From the treatment start date to radiological progression, up to 3 years)
- CRPCa development(From the date of randomization up to 3 years)
- Quality of life assessment(From admission to discharge, assessed up to 3 years)
- Complications(From admission to discharge, assessed up to 3 years)