An open-label, two-part, phase 2 clinical trial to investigate the safety and diagnostic performance of uPAR PET imaging for non-invasive classification of ISUP grades among patients with localised, untreated prostate cancer. - 64Cu-DOTA-AE105-101

Curasight A/S0 个研究点目标入组 168 人开始时间: 2023年12月18日最近更新: 2024年7月22日

适应症

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•Pathology-verified prostate adenocarcinoma, Pathology material available for central review, International Society of Urological Pathology (ISUP) grade 1 to 3, Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients) a.Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial. b.Other patients (including AS): N0/M0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial., Prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan) a.The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS. b.At least 1 core must be MRI guided.

•Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy, Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis)., Acute infections within the prostatic bed or lower urinary tract infections., Participants have inadequate bone marrow, kidney, liver, heart, or lung function

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