Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer

Summary

This is an open-label single arm clinical trial, plan to enroll approximately a total of 62 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 73. Inclusion criteria: To be eligible for inclusion, each patient must fulfill all of the following criteria: 1. Age equals or more than 20 years old 2. Willing to sign the informed consent 3. Pathology-proved intermediate to high risk group prostate cancer patients (PSA \> 10 ng/mL, or Gleason score 7-10, or clinical stage \>T2a) OR Prior radiotherapy or prostatectomy for prostate cancer with biochemical recurrence defined as: * post prostatectomy: increase in PSA of \> 0.2 ng/mL in two or more consecutive blood samples * post radiotherapy: PSA levels of ≥ 2 ng/mL above the post-therapy nadir 4. Life expectancy more than 3 months 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. Unable to give informed consent. 4. Allergy history to Ga68-PSMA ligand, significant abnormal lab data (ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI. 5. Patient had malignancy history

Timeline

Start

2017-06-22

Primary completion

2019-06-30

Completion

2019-06-30

Drugs

Indications