Status:
RECRUITING
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
Lead Sponsor:
Telix Pharmaceuticals (Innovations) Pty Limited
Collaborating Sponsors:
Grand Pharmaceutical (China) Co., Ltd.
Conditions:
Biochemical Recurrence of Malignant Neoplasm of Prostate
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 recur...
Eligibility Criteria
Inclusion Criteria:
-
Are able to understand and provide written informed consent document.
-
Are Chinese males aged ≥ 18 years.
-
Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).
- Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
- Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
-
Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
-
Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
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Are willing and able to comply with scheduled
Exclusion Criteria:
- Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
- Are participating or plan to participate in any drug or device clinical study during the study period.
- Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
- Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
- Have prior history of salivary gland disease or Paget's disease.
- Have a history of fracture and anemia within the last year.
- Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
- Is deemed not suitable for participating in this trial in the opinion of the investigator.
Key Trial Info
Start Date :
July 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05847348
Start Date
July 19 2023
End Date
July 30 2026
Last Update
July 3 2024
Active Locations (8)
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1
Peking University First Hospital
Beijing, China
2
Xiangya Hospital Central South University
Changsha, China
3
Nanfang Hospital Southern Medical University
Guangzhou, China
4
Fudan University Shanghai Cancer Center
Shanghai, China