68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery

PRIMARY OBJECTIVES:

I. To evaluate gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga-PSMA-11)
PET/CT for the detection of regional nodal metastases compared to pathology at radical
prostatectomy on a per patient basis.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo a single PET/CT scan over 45-60
minutes at week 1.

After completion of study, patients are followed up at 1-3 days.

Inclusion Criteria:

- Biopsy proven prostate adenocarcinoma

- Planned prostatectomy with lymph node dissection

- Intermediate to high-risk disease (as determined by elevated prostate specific antigen
[PSA] [PSA > 10], tumor [T]-stage [T2b or greater], Gleason score [Gleason score > 6]
or other risk factors)

- Able to provide written consent

- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
[ECOG]/World Health Organization [WHO] equivalent)

- Diagnostic CT or magnetic resonance imaging (MRI) as part of the PET study or
performed within one month of PSMA PET

Exclusion Criteria:

- Patients not capable of getting PET study due to weight, claustrophobia, or inability
to lay still for the duration of the exam

- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal
ablation techniques (high-intensity focused ultrasound ablation [HiFu])