Zopocianine for Prostate Cancer

This trial tests a new drug called Zopocianine, used with special imaging to identify cancerous tissue in men with prostate cancer. Researchers aim to determine the optimal dose and timing of the drug to enhance cancer detection during surgery. The trial seeks men diagnosed with prostate cancer who are scheduled for surgery. Candidates who have undergone a PSMA-PET scan for surgical planning in the past year may be suitable.

As a combined Phase 2 and Phase 3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval. Participants have the opportunity to contribute to advancements in prostate cancer detection.

Research has shown that Zopocianine (OTL78) is generally safe for people. Studies found it safe for patients with prostate cancer, with no major side effects reported. This suggests the treatment is safe to use. Additionally, Zopocianine may help doctors better detect prostate cancer during surgery, offering an extra benefit beyond its safety.¹²³⁴⁵

Most treatments for prostate cancer, like surgery, radiation, and hormone therapy, focus on removing or reducing cancer cells. But Zopocianine is different. This treatment uses a special dye, OTL78, that lights up cancer cells when exposed to near-infrared (NIR) light, helping surgeons see and target cancerous tissues more precisely during surgery. Researchers are excited about this because it could lead to more successful surgeries by ensuring all cancer cells are removed, potentially reducing the chance of cancer coming back and improving patient outcomes.

Research has shown that Zopocianine (OTL78) helps doctors see cancerous tissue more clearly during prostate surgery. Studies have found that it works well with Near InfraRed (NIR) imaging to highlight cancer cells. In this trial, participants will receive a single dose of 0.06 mg/kg Zopocianine before surgery. Patients in earlier studies tolerated OTL78 well, indicating its safety. The treatment effectively identified prostate tumors, the edges of tissue removed during surgery, and any remaining cancer. These findings suggest that using Zopocianine may enhance the accuracy of prostate cancer surgeries.¹³⁴⁶⁷