68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

Inclusion Criteria:

   - Biopsy proven prostate adenocarcinoma

   - Planned prostatectomy with lymph node dissection

   - Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], 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) performed within 30 days prior to
   the 68Ga-RM2 PET

Exclusion Criteria:

   - Inability to lie still for the entire imaging time (approximately 30 minutes)

   - Inability to complete the needed investigational and standard-of-care imaging
   examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

   - Any additional medical condition, serious intercurrent illness, or other extenuating
   circumstance that, in the opinion of the Investigator, may significantly interfere
   with study compliance