177Lu-PSMA-617 radioligand therapy versus Docetaxel in High-volume Metastatic Hormone-sensitive Prostate Cancer: A Randomized, Controlled, Phase 2 Non-inferiority Trial (LADDER) - LADDER

All India Institute of Medical Sciences New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年4月4日

研究概览

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•Histologically proven adenocarcinoma prostate
•High-volume metastatic disease (as established by 68Ga-PSMA-11 PET/CT) defined as presence of visceral metastasis or >=4 bone lesions with at least one extra-axial lesion
•Significant PSMA expression in 68Ga-PSMA-11 PET/CT defined as avidity of lesion being greater than that of normal liver
•ECOG performance 0-2
•Adequate renal function â?? eGFR >= 30 mL/min
•Stable haematological parameters:
•oHb >= 8 g/dL
•oNeutrophils >= 1500/mcL
•oPlatelets >= 75000/mcL
•Adequate liver function:
•oBilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
•oAST or ALT <= 1.5 x ULN (or <= 5.0 x ULN in the presence of liver metastases)
•oAlbumin >= 2.5 g/dL
•Prior treatments allowed:
•oFor de-novo mHSPC: prior ADT allowed if commenced within 90 days of randomization and no evidence of progressive disease; prior palliative radiotherapy or surgery allowed if conducted >=4 weeks prior to randomization
•oFor localized PCa progressing to mHSPC (all treatments completed >=6 months prior to randomization)
•ï?§<=36 months of ADT
•ï?§All other forms of prior therapies including radiation therapy, prostatectomy and lymph node dissection

•Prostate cancer with sarcomatous/spindle cell/small cell differentiation
•PSMA expression in 68Ga-PSMA-11 PET/CT less than liver
•Sjogren Syndrome
•Active malignancy other than prostate cancer
•Concurrent illness, including severe infection
•Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
•Prior treatment with docetaxel or novel anti-androgens

发起方

All India Institute of Medical Sciences New Delhi