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

NCT05847348 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-07-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Grand Pharmaceutical (China) Co., Ltd.

    collaborator OTHER

  • Telix Pharmaceuticals (Innovations) Pty Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2025-12-30
Completion
2026-07-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05847348 on ClinicalTrials.gov