drugset / Trial / NCT05847348
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
Phase 3
Recruiting
110 enrolled
Telix Pharmaceuticals (Innovations) Pty Limited
Grand Pharmaceutical (China) Co., Ltd. · collab
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2023-07-19
- Primary completion
- 2025-12-30
- Completion
- 2026-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-PSMA-11 | Diagnostic / imaging agent | 111 mbq | Intravenous |
| Subject | 68Ga-PSMA-11 | Diagnostic / imaging agent | 259 mbq | Intravenous |