Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging - Enzalutamide
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- CRPC
研究概览
简要总结
PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
详细描述
Rationale: Men, newly diagnosed with metastasized prostate cancer on PSMA PET/CT, who start on standard hormonal therapy, are additionally treated with either upfront chemotherapy or upfront extra androgen-receptor targeted agents ('ARTA'), as per guidelines' recommendations. The benefit in overall survival of these two options is similar, but important differences exist in patient-specific efficacy, costs, side-effects, and impact on quality of life. No predictive factors are available to individualize treatment choice. Currently, a one-size-fits-all strategy with hormonal therapy plus chemotherapy is usually followed.
Objective: To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.
Study design: Prospective, single arm, open label, non-interventional, non-therapeutic observational cohort study.
Study population: Patients >18 years with newly diagnosed, histologically proven prostate cancer with >3 skeletal or visceral metastatic lesions on the PSMA-PET/CT, who are considered eligible for upfront therapy (enzalutamide) in addition to standard hormonal therapy.
Main study parameters/endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Men >18 years of age.
- •Mentally competent and understanding of benefits and potential burden of the study.
- •Written and signed informed consent.
- •Histological confirmed diagnosis of adenocarcinoma of the prostate.
- •Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
- •Indicated to start on upfront therapy (enzalutamide).
- •Any initial PSA.
- •Any Gleason score.
- •Any T-stage.
- •Any N-stage.
- •Stage M1, with multiple / high volume metastasis: More than three (>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent.
排除标准
- •Concomitant malignancy (except from BCC of the skin).
- •History of prior diagnosed or treated PCa.
- •Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study.
- •Any known allergy for the upfront therapy.
- •Any known allergy for LHRH agonist or antagonist.
结局指标
主要结局
CRPC
时间窗: 12-24 months after start
Development of castration-resistant prostate cancer
次要结局
- Second line therapy(12-24 months after start)
研究者
Roderick van den Bergh
Dr. Roderick CN van den Bergh
UMC Utrecht