2024-514386-19-00招募中2 期
A phase I study of neoadjuvant treatment with 177-Lutetium-PSMA-617 with Ipilimumab in subjects with very high-risk prostate cancer who are candidates for radical prostatectomy (NEPI Trial)
Universitaetsklinikum Essen AöR1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年7月31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
- 58
- 试验地点
- 1
- 主要终点
- Feasibility will be defined as the ability to perform prostatectomy in at least 83,33 % of participants of a treatment arm 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks in the present study.
研究概览
简要总结
Co-primary endpoints of the study are feasibility and safety.
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
- •Must be ≥18 years of age
- •Sexually active patients must use a condom to prevent them from fathering a child and to prevent delivery of study treatment via seminal fluid to their partner for at least 14 weeks after the last dose of [177Lu]Lu‐PSMA‐617
- •Tumor tissue of both prostate biopsy and radical prostatectomy specimen available for local histology review and reference pathology by Professor Henning Reis (Department of Pathology, University Hospital Frankfurt)
- •Signed an informed consent form (ICF) indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Histologically confirmed adenocarcinoma of the prostate including following criteria: Very High‐risk defined by a total Gleason‐Score ≥4+4 (ISUP‐GG 4+5) and clinical stage cT3 (digital rectal examination or imaging based) plus clinical nodal status cN+ or Serum‐PSA level >20ng/ml
- •Exclusion of metastases (M0) on conventional imaging and maximum oligometastatic status (maximum 3 bone lesions) on PSMA PET imaging
- •Treatment naïve patients
- •Eastern Cooperative Oncology Group ECOG 0‐1
- •Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
- •Patients must be PSMA Positron Emission Tomography (PET) scan positive with a prostatic SUVmax > 12 (PRIMARY Score: 5) .
- •Following laboratory criteria must be obtained within 14 days prior to randomization: Bone Marrow reserve • White blood cells, WBC ≥ 2000/μL • Neutrophils ≥ 1500/μL • Platelets ≥ 100 x103/μL • Hemoglobin ≥ 9.0 g/dL Hepatic • AST/ALT ≤ 3 x ULN • Total Bilirubin ≤ 1.5 x ULN (except participants with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dL) Renal • Serum creatinine ≤ 1.5xULN Endocrine • TSH 0,4 ‐ 4,0 mU/l = 0,4 ‐ 4,0 μU/ml o If TSH is not in normal range, fT3 and fT4 must be determined o fT3 2,3 ‐ 4,5 pg/ml = 3,5 ‐ 7,0 pmol/l o fT4 0,8 ‐ 1,8 ng/dl = 8 ‐ 18 ng/l = 10 ‐ 23 pmol/l Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) Electrolytes: • Potassium: 3.5‐5 mmol/L • Sodium: 135‐145 mmol/L Pancreatic: • amylase, lipase ≤ 3 x ULN alkaline phosphatase (range to be assessed in context of oligometastatic disease) blood sugar < 200 mg/dL (11.1 mmol/L)
排除标准
- •Distant metastasis (clinical stage M1) on conventional imaging. Oligometastatic (maximum 3 bone lesions ) patients on exclusively PSMA PET imaging will not be excluded. Patients with PSA values below 20ng/ml and no evidence of nodal disease are excluded.
- •Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
- •Lack of availability for clinical follow‐up assessments
- •Other potential life‐threatening malignancies within the past five years requiring treatment
- •Serious cardiac, gastrointestinal, hepatic or pulmonary disease reducing life expectancy to less than five years
- •Patients with serious intercurrent illness, requiring hospitalization
- •Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders
- •Patients carrying organ transplants and/or receiving continuous immunosuppressive medication (other than steroid therapy of up to 10 mg prednisone per day)
- •The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition
- •Known hypersensitivity reaction to any of the components of study treatment
- •Known alcohol or drug abuse
- •Prior treatment with androgen receptor antagonists. Treatment with GnRH analogs prior to ICF signature
- •Participation in another clinical study and use of any investigational or non‐registered product (drug or vaccine) other than the study treatment within the 30 days before registration
- •Significant disease or condition which, in the investigator’s opinion, would exclude the patient from the study
- •Legal incapacity or limited legal capacity
- •Bilateral orchiectomy
- •History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
- •Use of any investigational agent ≤4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
- •Major surgery ≤4 weeks prior to randomization
- •Prior therapy with CTLA4 antibodies
- •Previous treatment with any of the following within 6 months of randomization: Strontium‐89, Samarium‐153, Rhenium‐186, Rhenium‐188, Radium‐223, Previous PSMA‐targeted radioligand therapy
- •Any immunosuppressive therapy given within the past 30 days prior to study drug administration (excluding physiologic steroid hormone replacement and / or steroid therapy up to a maximum dose of 10 mg prednisone or equivalent per day)
结局指标
主要结局
Feasibility will be defined as the ability to perform prostatectomy in at least 83,33 % of participants of a treatment arm 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks in the present study.
Feasibility will be defined as the ability to perform prostatectomy in at least 83,33 % of participants of a treatment arm 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks in the present study.
Safety of neoadjuvant treatment with ipilimumab and [177Lu]Lu-PSMA-617 RLT before radical prostatectomy will be characterized according to Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Safety of neoadjuvant treatment with ipilimumab and [177Lu]Lu-PSMA-617 RLT before radical prostatectomy will be characterized according to Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
次要结局
- Clinical activity is measured by pathologic complete response (pCR) and minimal residual disease (MRD), which is defined as a tumor burden of 5 mm or less in the largest dimensions.
- Disease-free survival measurements are also performed. Disease-free survival is defined as PSA progression-free survival up to 1 year after prostatectomy.
研究者
Professor Dr. Ulrich Krafft
Scientific
Universitaetsklinikum Essen AöR
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal CancerNCT07269249National Cancer Institute, Naples50
招募中
2 期
Phase II, multi‑cohort trial of neoadjuvant and post‑surgery IO102‑IO103 and pembrolizumab in patients with selected resectable tumors2022-502787-20-00IO Biotech ApS65
招募中
2 期
Prospective, randomized, neoadjuvant phase II study with combination immuno-oncology in primary clear cell renal cell cancer at risk for recurrence or distant metastases (NESCIO-trial; M21NSC; CA209-6DJ)2024-515514-40-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting69
招募中
1 期
Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver MetastasesNCT07277322Dan Feng24
招募中
2 期
Study of chemotherapy and immunotherapy for patients with lung cancer bounded in the thorax and potentially resectable2024-513731-24-00Fundacion GECP90