NCT05847348

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biochemical Recurrence of Malignant Neoplasm of Prostate
• Prostate Cancer
• BCR Prostate Carcinoma

Interventions

Type	Name	Description
DRUG	68Ga-PSMA-11	A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
OTHER	PET/CT or PET/MRI	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

Timeline

• Start date: 2023-07-19
• Primary completion: 2025-12-30
• Completion: 2026-07-30
• First posted: 2023-05-06
• Last updated: 2024-07-03

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated drug study