Phase II Study on the Safety and Effectiveness of Three Doses of OTL78 Injection

Sponsor: Clinton Bahler

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06849544

Provider View

This clinical trial is testing how well a new drug, OTL78, combined with special imaging, can help doctors find cancerous tissue in patients with prostate cancer during surgery.

Patient Parameters

Program Overview

The study aims to see if using a drug called Zopocianine (OTL78) with Near InfraRed (NIR) imaging can improve the detection of cancerous tissue in adults undergoing surgery for prostate cancer. This could help doctors better identify and remove cancerous tissue during prostate surgery.

Description

Prostate cancer is a major cause of cancer-related deaths, second only to lung cancer. Most prostate cancer cells have a protein called Prostate Specific Membrane Antigen (PSMA), which is found in over 90% of patients. The drug OTL78 targets this protein and lights up under special lighting, helping surgeons see cancerous tissue during surgery. This study will test how well this drug works in up to 15 patients who are having surgery to remove their prostate and nearby lymph nodes. The goal is to see if the drug helps doctors find and remove all cancerous tissue, reducing the chance of cancer being left behind. The study will also look at how different doses and timing of the drug affect its usefulness during surgery.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older.
  • Diagnosed with prostate cancer and classified as Grade Group 3 to 5, with certain conditions like suspected spread beyond the prostate or lymph node involvement.
  • Scheduled for standard robotic prostate surgery and lymph node removal.
  • Able to understand and follow study requirements, including attending follow-up visits.
  • Agree to use birth control or abstain from sex during the study and for six weeks after the last dose of the study drug. Sperm donation is not allowed during the study and for three months after the last dose.

Exclusion Criteria

  • Surgery planned using an extraperitoneal approach.
  • History of severe allergic reactions to products containing indocyanine green.
  • Allergies to any components of Zopocianine, such as DUPA, polyethylene glycol-dipeptide linker, or Chlorodye.
  • Poor kidney or liver function, as shown by specific blood tests.
  • Heart rhythm issues, with a QTc interval of 470 milliseconds or more on an ECG.
  • Any serious medical or neurological conditions that could affect safety or the study's goals, as determined by the study doctor.

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