Actively Recruiting
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
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-07-03
110
Participants Needed
8
Research Sites
30 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
Researchers are evaluating the effectiveness of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in detecting biochemical recurrence of prostate cancer in Chinese male patients who have elevated PSA levels after radical prostatectomy or radiotherapy. This Phase 3, prospective, open-label, single-arm, multicenter study focuses on patients with confirmed prostate adenocarcinoma experiencing biochemical recurrence. The study seeks to understand how well the imaging tracer 68Ga-PSMA-11, also known as Illuccix®, works in this population. Participants will receive a single intravenous dose of 68Ga-PSMA-11, ranging from 111 to 259 MBq, administered over 3 to 5 minutes. After 50 to 100 minutes post-injection, they will undergo PET/CT or PET/MRI scanning from mid-thigh to the skull while lying on their back with their arms overhead. This imaging procedure is designed to detect recurrent tumor sites. During the study, participants will be monitored for up to 12 months to assess the positive predictive value of 68Ga-PSMA-11 imaging based on biopsy, clinical follow-up, and conventional imaging. Adverse events and changes in clinical management will be tracked for 3 days post-imaging. Participants must comply with scheduled visits and assessments, including PSA measurements and safety evaluations, throughout the study.
CONDITIONS
Brief 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 male aged 18 years or older.
- Histopathologically confirmed prostate adenocarcinoma with prior radical prostatectomy and/or radical radiotherapy.
- Evidence of biochemical recurrence: PSA 6 0.2 ng/mL at least 6 weeks after prostatectomy or a rise of 6 2 ng/mL above nadir after radiation therapy.
- Karnofsky performance status of 60 or higher (or ECOG/WHO equivalent).
- Agree to use highly effective contraception for at least 28 days after 68Ga-PSMA-11 administration.
- Willing and able to comply with scheduled study procedures.
You will not qualify if you...
- History of other malignancy within past year, except non-metastatic skin basal cell or superficial squamous cell carcinoma and superficial bladder cancer.
- Prior radionuclide therapy within an interval of less than 10 physical half-lives before 68Ga-PSMA-11 administration.
- Participation in any other drug or device clinical study during this study period.
- Known allergy to 68Ga-PSMA-11 or its components.
- Unable to lie flat or remain still for PET scan.
- History of salivary gland disease or Paget's disease.
- History of fracture or anemia within last year.
- Abnormal physical exam, ECG, or lab tests affecting safety or compliance.
- Investigator deems participant unsuitable for the trial.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intravenous dose of 68Ga-PSMA-11 followed by a PET/CT or PET/MRI scan to detect biochemical recurrent prostate cancer.
1 visit (in-person)
Duration - 3 days
Participants are monitored for safety and clinical management outcomes after the diagnostic procedure.
1 to 2 visits
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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