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.
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
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.
Single group
68Ga-PSMA-11
DrugA single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
PET/CT or PET/MRI
Other interventionPET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11
Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up.
The PPV \[PPV (%) = TP\* /(TP + FP\*\*)\] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative).
Incidence of adverse events
Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events
Clinical management in biochemical recurrence patients.
The impact of 68Ga-PSMA-11 PET/CT or PET/MRI on clinical management in biochemical recurrence patients will be assessed through the completion of Medical Management Questionnaires completed prior to and after 68Ga-PSMA-11 PET/CT or PET/MRI.
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Telix Pharmaceuticals (Innovations) Pty Limited
Lead sponsor
Grand Pharmaceutical (China) Co., Ltd.
Collaborator
