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

68Ga-PSMA-11 PET/CT for Staging of Intermediate and High Risk Prostate Cancer Prior to Radical Prostatectomy

This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.

PRIMARY OBJECTIVE:

I. To assess the sensitivity and specificity of gallium Ga 68 gozetotide (68Ga-PSMA-11) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.

SECONDARY OBJECTIVES:

I. To assess the positive and negative predictive value of 68Ga-PSMA-11 PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis, and on a per patient basis using nodal regional correlation.

II. To assess sensitivity, specificity, positive and negative predictive value of 68Ga- PSMA-11 PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 20-50 minutes on day 1.

After completion of study, patients are followed up at 2-4 days, then at 12 months.

Inclusion Criteria:

• Biopsy proven prostate adenocarcinoma
• Considered for 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)

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])