克拉里蒂制药公司对新型前列腺癌成像测试的第三期试验已达到招生目标,显示出强的需求和FDA批准的潜力. Clarity Pharmaceuticals' Phase III trial for a new prostate cancer imaging test has met its enrollment goal, showing strong demand and potential for FDA approval.

克拉里蒂制药公司宣布其AMPLIFY试验的第三阶段,评估Cu-SAR-bisPSMA PET/CT用于检测治疗后 PSA 升高的男性前列腺癌复发,超过了其在美国和澳大利亚约220名参与者的目标招生. Clarity Pharmaceuticals has announced its Phase III AMPLIFY trial, evaluating Cu-SAR-bisPSMA PET/CT for detecting prostate cancer recurrence in men with rising PSA after treatment, has exceeded its target enrollment of about 220 participants across the U.S. and Australia. 在注射后1-4小时和24小时对成像进行评估的非随机、单臂研究旨在支持美国林业发展局的核准申请。 The non-randomized, single-arm study, which assesses imaging at 1–4 hours and 24 hours post-injection, is designed to support a U.S. FDA approval application. 9个月后迅速入学,尽管现有的PSMA PET选项——临床需求强劲。 Rapid enrollment in nine months—despite existing PSMA PET options—signals strong clinical demand. 成果将以早期的试验为基础,这些试验显示比标准成像的探测情况有所改善。 Results will build on earlier trials showing improved detection over standard imaging. 第二阶段审判(CLARIFY)正在进行,预计将于2026年结束。 A second Phase III trial, CLARIFY, is ongoing and expected to conclude in 2026. 迄今为止,全球已扫描了大约600名病人,过去一年超过350名。 To date, around 600 patients have been scanned globally, with over 350 in the past year.