177Lu-PSMA RADIOLIGAND THERAPY IN PATIENTS WITH LYMPH NODE METASTATIC HORMONE-SENSITIVE PROSTATE CANCER UNDERGOING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION - SHEPHERD trial

未提供0 个研究点目标入组 10 人开始时间: 2022年6月24日最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•-Men over 18 years of age
•-ECOG performance score (PS) 0-1
•-Histologically proven adenocarcinoma of the prostate cancer of any grade and/or stage
•-Any prostate-specific antigen (PSA)-level
•-Planned to undergo radical prostatectomy (RARP) and extended pelvic lymph node dissection (ePLND)
•-A pre-operative [68Ga] or [18F] PSMA PET/CT positive for lymphogenic metastatic disease (1-3 metastases; miN1) in the surgical template with a maximum of 6 weeks before study entry
•-An mpMRI of the abdomen with a maximum of 12 weeks before study entry
•-Deemed clinically fit for 177Lu-PSMA RLT
•-eGFR = 30 mL/min/1.73 m2
•-Hemoglobin (Hb) = 5.6 mmol/L
•-Leucocytes = 3.0 x 109/L
•-Thrombocytes = 100 x 109/l
•-Provided informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•-Previous treatment with any of the following within 6 months of inclusion:
•Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
•-Previous PSMA-targeted radioligand therapy
•-Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of inclusion
•-Known hypersensitivity to the components of the study therapy or its analogs
•-Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
•-Patients with signs of M1a-b-c disease on pre-operative PSMA PET/CT
•-Prior systemic hormonal therapy (ADT)

发起方

未提供