Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer
Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer
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
It is a phase II single-arm clinical trial. The primary endpoint is diagnostic sensitivity of
 the Ga-68 PSMA ligand in prostate cancer. The four outcomes (true positive, false positive,
 true negative, and false negative) can be defined based on the process as Figure 1 and
 formulated in a 2×2 contingency table, and the related sensitivity, specificity, and accuracy
 will be calculated based on the test results of enrolled subjects. All subjects enrolled must
 meet eligibility criteria based on the inclusion/exclusion criteria detailed in Section 5.4
 and 5.5.

 Time elapsed from the last PSA determination until PET was no more than 2 weeks in all
 patients. Patients will receive complementary workups including MRI (for patients suspicious
 for local or regional node recurrence), bone scan (for patients suspicious for distant bone
 metastasis), contrast CT (for patients suspicious for visceral organ metastasis or lung
 metastasis) subsequently after Ga68-PSMA ligand PET/CT scan no longer than two weeks.

 All of the images were interpreted by a team of two nuclear medicine physicians and one
 radiologist. In cases of questionable findings, the decision was made by consensus of at
 least two observers using pre-specified criteria. All of the readers were blinded to the
 patient's clinical history, blood tests, and previous imaging findings. If patient have
 consistent findings between Ga68 PSMA ligand PET/CT and other complementary workups, the
 patients are deemed as true positive or negative. For patients with discrepancy image
 findings between Ga68 PSMA ligand PET/CT and the other complementary workups, biopsy, needle
 aspiration or operation will be arranged for histology confirmation. The final results of
 Ga68-PSMA ligand PET/CT scan will be depend on the consensus of multidisciplinary tumor board
 based on all integrated informations.
Inclusion 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

 Exclusion Criteria:

 1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie
 still.

 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, and high risk to
 conduct examination after evaluations of PI.