Actively Recruiting
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-07-03
110
Participants Needed
8
Research Sites
158 weeks
Total Duration
On this page
Sponsors
T
Telix Pharmaceuticals (Innovations) Pty Limited
Lead Sponsor
G
Grand Pharmaceutical (China) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Chinese males aged 18 years or older
- Histopathologically confirmed prostate adenocarcinoma
- Have undergone radical prostatectomy and/or radical radiotherapy with biochemical recurrence
- Post radical prostatectomy PSA 20.2 ng/mL measured 6 weeks after surgery
- Post radiation therapy PSA rise of nadir + 2 ng/mL per ASTRO-Phoenix definition
- Karnofsky performance status of at least 60 (or equivalent ECOG/WHO status)
- Agree to use effective contraception for at least 28 days after 68Ga-PSMA-11 injection
- Willing and able to comply with study schedule
You will not qualify if you...
- History of other malignancies within the last year except certain non-metastatic skin cancers and superficial bladder cancer
- Prior use of radionuclides less than 10 physical half-lives before 68Ga-PSMA-11 administration
- Participation or planned participation in another drug or device clinical study during this study
- Known hypersensitivity to 68Ga-PSMA-11 or its components
- Inability to lie flat or remain still for PET scanning or intolerance to PET scan
- History of salivary gland disease or Paget's disease
- History of fracture or anemia within the last year
- Abnormalities in physical exam, ECG, or lab tests affecting safety or compliance
- Investigator's judgment of unsuitability for trial participation
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Peking University First Hospital
Beijing, China
Actively Recruiting
2
Xiangya Hospital Central South University
Changsha, China
Actively Recruiting
3
Nanfang Hospital Southern Medical University
Guangzhou, China
Actively Recruiting
4
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
5
West China Hospital of Sichuan University
Sichuan, China
Actively Recruiting
6
Wuhan Union Hospital
Wuhan, China
Actively Recruiting
7
Zhongnan Hospital of Wuhan University
Wuhan, China
Actively Recruiting
8
Affiliated Hosptial of Jiangnan University
Wuxi, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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