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

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.
• 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.