The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Status:
Completed
Trial end date:
2021-07-27
Target enrollment:
Participant gender:
Summary
This is an open-label single arm clinical trial, Plan to enroll approximately a total of 43
evaluable subjects. According to the estimated missing rate 15%, the sample size in this
study is 51.
Inclusion criteria:
To be eligible for inclusion, each patient must fulfill all of the following criteria:
1. Males with 40-85 years of age and life expectancy more than 3 months
2. Pathology-proved prostate cancer patients and classified as clinical stage III or IV
(including lymph node or bone metastasis)
3. Willing to sign the informed consent
Exclusion criteria:
Patient who has any of the following criteria will be excluded from the trial:
1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie
still, consciousness unclear, vital sign unstable.
2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and
allergy to medium contrast.
3. Significant abnormal lab data (AST or ALT more than three times of normal value), and
high risk to conduct examination after evaluations of PI.
4. Patient had previous malignancy history
5. Patient had known allergy history or is probably allergy to Ga68-PSMA-11