PHASE III CHINA REGISTRATION STUDY FOR ILLUCCIX

A study investigating how well ⁶⁸Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patients.

1. Are able to understand and provide written informed consent document.
2. Are Chinese males aged ≥ 18 years.
3. 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).
   1. Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
   2. Post radiation therapy – ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
4. Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
5. Agree to practice a highly effective method of contraception for at least 28 days after ⁶⁸Ga-PSMA-11 administration.
6. Are willing and able to comply with scheduled

1. 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.
2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of ⁶⁸Ga-PSMA-11.
3. Are participating or plan to participate in any drug or device clinical study during the study period.
4. Have a known hypersensitivity to the active ingredient or its components of ⁶⁸Ga-PSMA-11.
5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
6. Have prior history of salivary gland disease or Paget’s disease.
7. Have a history of fracture and anemia within the last year.
8. 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.
9. Is deemed not suitable for participating in this trial in the opinion of the investigator.