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A multicenter, randomized, controlled phase II study: Efficacy and safety of PSMA-targeted radioligand therapy I-131-1095 (1095) plus enzalutamide (enza) in 18F-DCFPyL PSMA scan avid, metastatic castration-resistant prostate cancer (mCRPC) patients post-abiraterone (abi) progression (ARROW)

Journal of Clinical Oncology Feb 28, 2020

Yu EY, Laidley D, Pouliot F, et al. - Researchers describe an open-label, randomized (2:1) trial, named ARROW, to test enza plus 1095 or enza alone among pts with progressive mCRPC who earlier treated with abi. At ~40 sites in the US and Canada, treatment will be provided to ~120 pts (80: 1095 + enza; 40: enza alone). Eligibility criteria included at least 18 years of age, metastatic disease shown by bone scan or soft tissue lesions measurable per RECIST 1.1 on CT/MRI, being PSMA-avid as ascertained by 18F-DCFPyL PET/CT, having proof of biochemical or radiographic progression on abi, and being ineligible for or deny to receive chemotherapy. The pts will be administered enza (prescribed per approved labeling) with or without 1095 (100 mCi dose, followed by up to 3 additional dose(s) given at least 8 weeks apart, as determined by dosimetry assessment and occurrence of dose-limiting events). The efficacy of 1095 plus enza vs enza alone, depending on PSA response (verified PSA decline ≥ 50%) rate as per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, will be determined as the primary objective. As additional objectives, experts will evaluate objective response rate depending on PCWG3-altered RECIST 1.1, progression-free survival defined as the first occurrence of radiographic progression (PCWG3-modified RECIST 1.1), unequivocal clinical progression, or mortality from any reason, duration of response, overall survival, as well as the safety and tolerability of 1095 radioligand therapy.
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