Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- PSA-RR
研究概览
简要总结
This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.
详细描述
The aim of the registry is to collect data of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium 177 (177Lu)-PSMA outside of a clinical trial to assess "real world" anti-tumour utility. The primary objective is to assess prostate specific antigen (PSA) response rate to 177Lu-PSMA in men with mCRPC.
Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.
The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.
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 mCRPC
- •Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
- •Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy
- •Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines
排除标准
- 未提供
结局指标
主要结局
PSA-RR
时间窗: From baseline through to progression or death until registry completion (approx. 5 years).
Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.
次要结局
- Radiographic progression-free survival (rPFS)(From date of treatment through to progression or death until registry completion (approx. 5 years).)
- PSA progression free survival (PSA-PFS)(From date of treatment through to progression or death until registry completion (approx. 5 years).)
- Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0(From date of treatment to 12 weeks after completing study treatment.)
- Overall survival (OS)(From date of treatment, up until 18 months after the last patient commences treatment.)
- EORTC QLQ-C30(From baseline through to progression or death until registry completion (approx. 5 years).)
- PPI(From baseline through to progression or death until registry completion (approx. 5 years).)