drugset / Trial / NCT05847348

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

NCT05847348

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

EvaluationDrugModalityDoseRoute
Subject 68Ga-PSMA-11 Diagnostic / imaging agent 111 mbq Intravenous
Subject 68Ga-PSMA-11 Diagnostic / imaging agent 259 mbq Intravenous

Indications