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

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Radiopharmaceuticals

Criteria

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.