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

Eligibility 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.