Neoadjuvant [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Oligometastatic Prostate Cancer Diagnosed Using [68Ga]Ga-PSMA-11 PET Imaging Followed by Radical Prostatectomy: A Prospective Phase II Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy
研究概览
简要总结
Prospective single-center phase II study to evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy [177Lu]Lu-PSMAI&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using [68Ga]Ga-PSMA-11 PET examination.
Ten patients with oligometastatic primary PCa diagnosed using [68Ga]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
- •Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- •Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
- •Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.
- •Patients must be able to sign Informed Consent Form
排除标准
- •Concomitant participation in any other interventional trial
- •Concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial.
- •Nonmetastatic PCa on [68Ga]Ga-PSMA-11 imaging
- •>5 osseous metastases on [68Ga]Ga-PSMA-11 imaging
- •Visceral metastases, apart from lungs
- •Age > 75 years.
- •Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
- •Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
- •Complete urinary out-flow obstruction or severe unmanageable urinary incontinence
研究组 & 干预措施
Oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging
Patients with oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases will receive 2 cycles of 5 GBq [177Lu]Lu-PSMA I&T at 6-week intervals prior radical prostatectomy.
干预措施: [177Lu]Lu-PSMA I&T (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy
时间窗: 12 months
Using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Furthermore, regular estimation of patient's ability to perform their usual everyday activities using Karnofsky performance status scale that ranges between a maximum of 100 percent (no restrictions) and 0 percent (death) and Eastern Cooperative Oncology Group Status scale that ranges from 0 (complete health) to 5 (death).
次要结局
- PSA response to neoadjuvant PSMA-RLT and radical prostatectomy(24 months)
- Evaluate pathologic response at radical prostatectomy(24 months)
- Estimate time to castration-resistant prostate cancer(24 months)
- Assess quality of life under the systemic PSMA-RLT(24 months)
- Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy(24 months)
- Quantification of circulating free tumor DNA (ctDNA)(24 months)
- Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,(24 months)
研究者
Sazan Rasul, MD, PhD
Physician and post-doctoral researcher
Medical University of Vienna