RecruitingPhase 3NCT05847348

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


Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

110 participants

Start Date

Jul 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of imaging scan using a radioactive tracer called 68Ga-PSMA-11 to see how well it can detect prostate cancer that has come back after surgery or radiation treatment in Chinese patients. A rising PSA blood test after initial treatment can signal recurrence, but standard scans often can't find where it is — this PET scan may do better. **You may be eligible if...** - You are a Chinese male aged 18 or older - You have a confirmed diagnosis of prostate cancer and have been treated with surgery or radiation - Your PSA (a blood marker for prostate cancer) has risen again after treatment, suggesting the cancer may have returned - You are willing to undergo the imaging scan **You may NOT be eligible if...** - You have not had prior radical prostatectomy or radiotherapy - You are currently receiving hormone therapy or other systemic prostate cancer treatment - You have had another cancer in the past 5 years - You are unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-PSMA-11

A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes

OTHERPET/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


Locations(8)

Peking University First Hospital

Beijing, China

Xiangya Hospital Central South University

Changsha, China

Nanfang Hospital Southern Medical University

Guangzhou, China

Fudan University Shanghai Cancer Center

Shanghai, China

West China Hospital of Sichuan University

Sichuan, China

Wuhan Union Hospital

Wuhan, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Affiliated Hosptial of Jiangnan University

Wuxi, China

View Full Details on ClinicalTrials.gov

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NCT05847348


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