An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Biomarkers value in the response to therapy
研究概览
简要总结
Participants to the study will be assigned to 7 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.
In all patients, 12 ml of blood sample will be collected in EDTA tube for analysis of biological biomarkers in different time points.
详细描述
Participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry.
Group 0 (set-up): blood sampling and rectal swab will be collected at a single time-point during the PC treatment. No follow-up is required.
Group 1a (control): the first blood sampling will be performed within 4 weeks since the negative biopsy; subsequent samplings will be done according to a schedule comparable to that of Group 1 up to 1 year or evidence of tumor, whichever occurs first.
Group 1, Group 2 and Group 3: the first blood sampling will be performed before radical treatment or HT start or CT start, on the basis of the planned antitumor therapy; subsequent sampling will be done after radical intervention at 4 weeks (only for Group 1) and then every 3 months (or more frequently if clinically indicated), up to 3 years or evidence of tumor recurrence/progression (radiological or biochemical), whichever occurs first.
At the time of recurrence/progression, patients of Group 1 could become part and could be followed as per Group 2, and patients of Group 2 could become part and could be followed as per Group 3.
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
- •General inclusion criteria (for entering all groups)
- •Age ≥ 18 years
- •Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated
- •Written Informed Consent
- •Inclusion criterion only for entering Group 0
- •Patients with a known diagnosis of CSPC or CRPC
- •Inclusion criterion only for entering Group 1a
- •Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer
排除标准
- •General exclusion criteria (for entering all groups)
- •Active infection requiring treatment
- •Decrease of general condition
- •Concomitant severe comorbities
- •Difficult socioeconomic conditions making regular follow up unfeasible.
- •Need of concomitant steroids at study entry and during the study
- •Diagnosis of second tumor in the previous 5 years
- •Exclusion criterion only for entering Group 0
- •No antibiotic treatments in the previous 2 months before enrollment
- •Exclusion criteria only for entering Group 1
- •Previous radical surgery and / or radical radiotherapy
- •Previous hormonal treatments
- •Exclusion criteria only for entering Group 2
- •No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics)
- •Previous hormonal treatments for advanced disease
- •Exclusion criterion only for entering Group 3
- •No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)
结局指标
主要结局
Biomarkers value in the response to therapy
时间窗: 3 years
To assess the value of MDSCs, NLR, cytokines as biomarkers of clinical outcome at different stages of disease and their correlation with PSA, the marker usually used for PC
次要结局
- Biomarkers inter and intra variability(3 years)
- Metabolomic and metagenomic analysis(3 years)