eoadjuvant [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostatecancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Study - Neoadjuvant PSMA-RLT in oligometastatic PCa

Medical University of Vienna0 个研究点目标入组 10 人开始时间: 2023年1月31日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•- Patients must be adults between 18 and 75 years of age.
•- 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.
•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 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- 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
•- more than 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

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