Real World Clinical Practice Study to Assess the Feasibility and Impact of Liquid Biopsy-based Genomic Profiling on Treatment Decision Making for Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- To evaluate the feasibility of a liquid-biopsy based Comprehensive Genomic Panel (CGP) test in the management of mPC patients, following a patient-centric approach
研究概览
简要总结
HOPE Prostate is an observational study that aims at promoting research against metastatic prostate cancer by means of collective research led by patients (patient-centric trial). Patients with metastatic prostate cancer living in Spain will voluntarily register and fulfil their journey in the study through the study's digital tool. Mainly they are prompted to answer questionnaires about their disease, and to provide a blood sample and an archival tumor biopsy. In HOPE Prostate these samples will be genomically analyzed and every patient case will be presented in a multidisciplinary molecular advisory board (MAB). The MAB will issue a plain report explaining the significance of the results and will try to enumerate future therapeutic options that match patient history and his genomic profile. Finally, patients will have to answer short follow-up questionnaires twice a year for 3 years.
The study data will allow us to advance implementing precision medicine to improve the management of current and specially future metastatic prostate cancer patients.
详细描述
HOPE PROSTATE - SOLTI-2102 is a national, prospective, real-world clinical practice study for patients diagnosed with metastatic prostate cancer (mPC) who are about to receive, or receiving, or completed treatment for advanced disease under standard clinical practice conditions, regardless of where they are receiving their medical care (academics vs community practices).
Patients will lead their own inclusion and, participation, and self-provide follow-up data in the study through a digital tool that will guide them in every step of the journey. The digital tool will collect general patient characteristics and demographics data, informed consent, disease characteristics, diagnostic tools employed along their oncological history, sample collection dates (for tissue,blood and saliva), genetics and tumor mutations, treatment history, patient's expectations and perceptions with regards to the process of undergoing genomic tumor testing and clinical trial experience from patients living with mPC. Moreover, when patients involve their physicians, they will receive notifications from the platform with molecular reports and an invitation to participate in the periodic Molecular Advisory Boards of the study (MAB).
The study will be in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines and applicable regulatory requirements. Approval of the study protocol will be from an Independent Ethics Committee (IEC).
Patients will request to participate in HOPE-PROSTATE through the study website and a personal session in the digital tool, will be created. Then:
- In a short inclusion questionnaire patients will introduce some demographic and medical data, and if available, medical reports.
- A medical monitor will validate that the inclusion and exclusion criteria are met and will contact patients to explain the study procedures, objectives and answer questions.
- Upon validation, patients will be contacted through the digital tool to give their informed consent or alternatively in paper (at a partner local laboratory).
- After informed consent validation, the digital tool will inform them of the steps to follow to proceed with their patient journey.
- Patients will fill out a short questionnaire to assess their pre-test expectations with regards to anticipated implications of testing and motivations to undergo testing.
- Before results obtention, patients will be required to complete a more extensive questionnaire about their medical history to use it at the Molecular Advisory Board (MAB) meeting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Male patients living in Spain.
- •Age ≥18 years.
- •Signed informed consent before any screening procedure.
- •Metastatic PC of any subtype confirmed both pathologically and radiologically (stage IV disease).
- •The subjects must be about to receive, or receiving, or will have completed treatment for their metastatic disease with any line of treatment in either a clinical trial or the standard of care healthcare setting.
- •Eastern Cooperative Oncology Group (ECOG) 0-1.
排除标准
- •Inability to consent or conform to the processes involved in a clinical study.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
结局指标
主要结局
To evaluate the feasibility of a liquid-biopsy based Comprehensive Genomic Panel (CGP) test in the management of mPC patients, following a patient-centric approach
时间窗: Ongoing basis during 5 years of study duration
Percentage of patients for whom a liquid biopsy result can be obtained.
To evaluate the impact of a liquid-biopsy based CGP test in the management of mPC patients, following a patient-centric approach
时间窗: Ongoing basis during 5 years of study duration
Proportion of patients with a putatively targetable (ESCAT levels I-III) alteration detected.
次要结局
- To describe the genomic landscape of mPC in a real-world population beyond clinical trials using validated targeted sequencing assays in tissue and ctDNA.(Ongoing basis during 5 years of study duration)
- To study the concordance rate for key genomic alterations between ctDNA and tumor targeted sequencing (in a subset of patients who have both samples available).(Ongoing basis during 5 years of study duration)
- To study the clinical impact of genomic testing in terms of matched therapies prescribed from treating physicians.(Ongoing basis during 5 years of study duration)
- To study the feasibility of liquid-biopsy based genomic testing in patient subsets: metastatic hormone-naïve and castration-resistant mPC(Ongoing basis during 5 years of study duration)
- Description Overall Survival (OS) among the included patients(Ongoing basis during 5 years of study duration)
- Description Progression Free Survival (PFS) of treatments aimed at identified alterations(Ongoing basis during 5 years of study duration)