2022-500838-28-00招募中2 期
A Phase I/II Study of Neoadjuvant, Intra-arterial Administration of [177Lu]Lu-PSMA-617 in Subjects with High-risk, Localised or Locally Advanced Prostate Cancer who are Candidates for Radical Prostatectomy (LUPUS)
Universitaetsklinikum Essen AöR1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年11月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Adverse Events related to intra-arterial [177Lu]Lu-PSMA-617 therapy
研究概览
简要总结
- Safety and tolerability of intra-arterial [177Lu]Lu-PSMA-617 in the neoadjuvant treatment of patients with high-risk, localised or locally advanced prostate cancer scheduled for radical prostatectomy
- Feasibility of intra-arterial [177Lu]Lu-PSMA-617 for neoadjuvant treatment of patients with high-risk, localised or locally advanced prostate cancer scheduled for radical prostatectomy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate including the following criteria: - High-risk prostate cancer defined by: a) a total Gleason sum score ≥4+4 (=ISUP Grade Groups 4 5), or b) any Gleason sum score and serum PSA-level ≥ 20 ng/mL or - Locally advanced high-risk prostate cancer (≥pT3a) defined as a) Extracapsular extension confirmed by mpMRI or PSMA-PET scan and/or b) Positive pelvic lymph nodes on pre-study PSMA-PET scan or c) Suspicion of pelvic lymph node involvement (cN1) on conventional imaging
- •Treatment-naïve patients for adenocarcinoma of the prostate
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 1
- •Candidate eligible for intra-arterial treatment as per investigator
- •Candidate scheduled for radical prostatectomy with pelvic lymph node dissection as per the investigator
- •Adequate bone marrow function, liver and renal function
- •Patients must be willing to use a condom for all sexual activities
- •Patients must have evidence of PSMA-positive disease as seen on a PSMA-PET scan
排除标准
- •Distant metastasis (clinical stage M1)
- •Prior treatment with androgen receptor antagonists. Treatment with GnRH analogues prior to ICF signature
- •Bilateral orchiectomy
- •History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
- •Major surgery ≤4 weeks prior to inclusion
- •Previous treatment with radioligands within 6 months before inclusion
结局指标
主要结局
Adverse Events related to intra-arterial [177Lu]Lu-PSMA-617 therapy
Adverse Events related to intra-arterial [177Lu]Lu-PSMA-617 therapy
Days of delay of scheduled surgery due to AEs related to intra-arterial [177Lu]Lu-PSMA-617 therapy
Days of delay of scheduled surgery due to AEs related to intra-arterial [177Lu]Lu-PSMA-617 therapy
次要结局
- PSA-response
- Pathological response as measured by pathological complete response (pCR) and minimal residual disease (MRD), defined as a tumour burden of 5 mm or less in greatest dimensions.
研究者
Principle Investigator/legal representative
Scientific
Universitaetsklinikum Essen AöR
研究点 (1)
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