[18F]FLOR (FC303) PET/CT Scan for the Detection of Prostate Cancer

Inclusion Criteria

• Males >= 18 years of age
• Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements
• Histologically confirmed adenocarcinoma of the prostate
• Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or magnetic resonance imaging [MRI]), or whole-body bone scan within 8 weeks of day 1
• At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
• Serum bilirubin =< 1.5 times the upper institutional limits of normal
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times the upper institutional limits of normal
• Serum creatinine =< 1.5 times the upper institutional limits of normal
• Absolute neutrophil counts >= 1,500 /mm^3
• Platelets >= 100,000/mm^3
• All electrolytes must be within normal limits or judged not clinically significant by the investigator

Exclusion Criteria

• Subjects administered any radioisotope within five physical half-lives prior to study drug injection
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion