Prostate Oligometastatic Cancer Management Driven by Disease Biology et/or Immunoactivity (PROMETEO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Validation of the prognostic significance of CTCs in a prospective cohort of OMPC patients undergoing SBRT
研究概览
简要总结
Currently, despite the advent of next-generation imaging has improved the detection of Oligometastatic prostate cancer (OMPC), prognostic biomarkers able to stratify patients and monitor treatment response are lacking and urgently needed. Mounting evidence suggests that molecular profiling of the disease and host immune activity evaluation can reveal OMPC heterogeneity and address the above unmet clinical need.
This study aims at combining the analysis of several biomarkers to improve the prognostic stratification of OMPC patients
详细描述
Currently, despite the advent of next-generation imaging has improved the detection of Oligometastatic prostate cancer (OMPC), prognostic biomarkers able to stratify patients and monitor treatment response are lacking and urgently needed. Mounting evidence suggests that molecular profiling of the disease and host immune activity evaluation can reveal OMPC heterogeneity and address the above unmet clinical need.
Liquid biopsy, defined as the sampling and analysis of tumor-derived analytes [i.e.: circulating tumor cells (CTCs), or circulating tumor DNA (ctDNA)] from blood, represents a powerful tool to assess in real-time the evolving landscape of cancer, identify prognostic and predictive biomarkers and detect resistance to therapies in several cancers, including Prostate Cancer (PC).
Additionally, the same blood sample allows the profiling of tumor-associated components, such as circulating immune cells, which may give clues at the systemic level about the dynamic and complex host-tumor interaction. It is non-invasive, easily repeatable, and cost-effective. In this regard, preliminary results derived from clinical studies indicate that the analysis of tumor material circulating in peripheral blood, combined with the study of the host immune response might be pivotal. This study aims at combining the analysis of several biomarkers, associated with both tumor (CTC and cfDNA) and host (TCR), with a micro-invasive approach, such as liquid biopsy, to improve the prognostic stratification of OMPC patients compared to conventional laboratory test (PSA) and imaging exams (Choline- or PSMA-PET imaging).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Prospective cohort
- •>18 years old
- •Histologic confirmation (primary or metastatic tumor) of Acinar Adenocarcinoma of Prostate
- •Hormone-sensitive OMPC defined as ≤3 metachronous metastases (bone and/or lymph node) detected within the past 6 months with Choline/PSMA PET-CT following prostate specific antigen (PSA) rising after primary treatment (surgery and/or radiotherapy) with curative intent as defined by European Association of Urology criteria (EAU).
- •Controlled primary tumor
- •Prior salvage treatment to the primary prostate cancer is allowed.
- •PSA ≤ 50 ng/mL
- •Testosterone ≥ 0.5 ng/mL
- •ADT associated to the primary treatment concluded more than 6 months prior to the enrollment.
- •Patients eligible for a course of SBRT on bone and/or lymph node metastatic sites
- •Patients must have a life expectancy ≥ 12 months and an ECOG performance status ≤ 2
- •Patients must have normal organ and marrow function defined as:
- •Leukocytes ≥2000/µL
- •Absolute Neutrophil Count ≥1000/µL
- •Platelets ≥50000/µL
- •Patients amenable to understand and sign written informed consent documents
排除标准
- •Prospective cohort
- •Spinal cord compression or impending spinal cord compression.
- •Suspected pulmonary and/or liver metastases
- •Patient receiving any other investigational agents
- •Patient is participating in a concurrent treatment protocol
- •Prior treatments for hormone-sensitive OMPC
- •Serum creatinine > 3 times the upper limit of normal.
- •Total bilirubin > 3 times the upper limit of normal.
- •Liver Transaminases > 5-times the upper limit of normal.
- •Unable to lie flat during or tolerate PET/CT or SBRT.
- •Previous history of cancer other than non-melanoma skin cancer in the last 5 years
- •Traumatic bone events in the 4 weeks before PET
结局指标
主要结局
Validation of the prognostic significance of CTCs in a prospective cohort of OMPC patients undergoing SBRT
时间窗: up to 3 years
To verify if a cut-off value of ≥5 CTC/7.5 mL of blood is prognostic of worst outcome in terms of distant progression-free survival (DPFS). Prognostic value will be measured as hazard ratio and relative 95% confidence intervals. DPFS will be defined as the time between the first day of SBRT and the detection at restaging imaging of clinical disease outside the treatment field
次要结局
- ADT-free survival and TCR(up to 3 years)
- Identify signatures in cfDNA of prognostic significance in terms of ADT-free survival(up to 3 years)
- time to castration resistant Prostate Cancer and CTC(up to 3 years)
- Overall survival and CTC(up to 3 years)
- Biochemical-PSF and TCR(up to 3 years)
- Local control and CTC(up to 3 years)
- Local control and TCR(up to 3 years)
- Identify signatures in cfDNA of prognostic significance in terms of time to castration resistant Prostate Cancer(up to 3 years)
- TCR values(up to 3 years)
- cfDNA(up to 3 years)
- prognostic value of the combination of different biomarkers(up to 3 years)
- Biochemical-PSF and CTC(up to 3 years)
- Distant-PSF and CTC(up to 3 years)
- Overall survival and TCR(up to 3 years)
- Distant-PSF and TCR(up to 3 years)
- Identify signatures in cfDNA of prognostic significance in terms of Biochemical-PSF(up to 3 years)
- Identify signatures in cfDNA of prognostic significance in terms of Distant-PSF(up to 3 years)
- Identify signatures in cfDNA of prognostic significance in terms of Local control(up to 3 years)
- ADT-free survival and CTC(up to 3 years)
- time to castration resistant Prostate Cancer and TCR(up to 3 years)
- Identify signatures in cfDNA of prognostic significance in terms of Overall survival(up to 3 years)