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: 0
• Participant gender: Male

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion 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:

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