[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with prostate cancer and biochemical but not radio-morphological local recurrence after primary therapy with curative intent: A Prospective Phase II Study - PSMA-RLT in biochemically recurrent prostate cancer

Medical University of Vienna0 个研究点目标入组 20 人开始时间: 2023年1月31日最近更新: 2024年2月26日

研究概览

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•Patients must be adults between 18 and 80 years of age.
•Patients with BCR after RP and RT with a PSA doubling-time (DT) of = 12 months.
•No hormonal therapy within the last 12 months or recovered testosterone levels.
•PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- 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 one year.
•- 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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