Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients

Inclusion Criteria

• Inclusion criteria - Male subjects aged >18 years. - Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy. - Ability to lie still for MRI scanning. - Patients must be able to provide written informed consent. - Glomerular filtration rate (GFR) > 60 mL/min within a 30 days of the research MRI. Key exclusion criteria - Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease. - Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections. - Patients with uncontrolled diabetes or hypertension. - Patients with active non-prostate malignancy. - Patients with contraindications for MRI including implantable pace makers, cochlear implants. - Patients with uni- or bilateral hip prosthesis. - Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments. - Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy. - Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result. - Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection. - Is determined by the investigator that the patient is clinically unsuitable for the study. - Is incapable of understanding the language in which the information for the patient is given. - Participation in a concurrent clinical trial or in another trial within the past 30 days.