Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer
Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
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