Clinical Trial

68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients

Unknown Phase 3
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Record status
This record was last updated July 3, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT05847348
Lead Sponsor Telix Pharmaceuticals (Innovations) Pty Limited
Collaborators: Grand Pharmaceutical (China) Co., Ltd.
Conditions Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer, BCR Prostate Carcinoma
Enrollment 110 participants
Start Date 2023-07-19
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-03