68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer
Telix Pharmaceuticals (Innovations) Pty Limited
110 participants
Jul 19, 2023
INTERVENTIONAL
Conditions
Summary
This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.
Eligibility
Plain Language Summary
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Interventions
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
PET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11
Locations(8)
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NCT05847348