NL-OMON52075招募中2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
排除标准
- •- 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)
- •- >3 lymph node metastases on preoperative PSMA PET
- •- Complete urinary incontinence, not willing to have an indwelling urinary
研究者
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