MT218 Injection for Prostate Cancer

This trial explores the effectiveness of the MT218 injection (a Gd(HP-DO3A) conjugated peptide) in enhancing MRI scans to identify prostate cancer in patients scheduled for prostate removal. The study aims to determine the optimal dose of MT218 for these scans. Men with a confirmed Gleason score between 8 and 10 for prostate cancer, who have undergone an MRI and a biopsy, and can remain still for an MRI, might be suitable candidates. This trial could enhance how doctors visualize prostate cancer, potentially leading to better treatment decisions. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in prostate cancer imaging.

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking any MRI contrast agents, you must not have received them within 48 hours before or 24 hours after the MT218 injection.

Research has shown that MT218, a special agent used in MRI scans, is well-tolerated by healthy men. Studies have found that MT218 appears safe, as participants did not report any major side effects. This suggests MT218 is generally safe for people.

In early tests, MT218 demonstrated strong properties important for its effectiveness and safety. It also showed higher uptake in prostate cancer cells, potentially improving imaging of these cells.

Most treatments for prostate cancer involve hormone therapy, surgery, radiation, or chemotherapy. But MT218 is different because it is delivered as a single intravenous injection while using advanced MR imaging to monitor its effects. Researchers are excited about MT218 because it introduces a new approach by varying doses to determine optimal levels for effectiveness, potentially improving precision in treatment. The use of MRI during administration could also provide real-time insights into how the treatment interacts with cancer cells, offering a more tailored therapy option. This method sets MT218 apart from current standards that often require longer courses of treatment and less precise monitoring.

Research shows that the MT218 injection, which trial participants will receive, holds promise for detecting aggressive prostate cancer. Studies indicate that MT218 enhances MRI images more effectively than standard methods, aiding in the identification of aggressive tumors. The drug binds well to prostate cancer cells, making them more visible in scans. Additionally, MT218 distinguishes between aggressive and less severe prostate cancers. These features suggest that MT218 could significantly improve the identification and treatment of prostate cancer.¹²⁵⁶⁷