Study on the Safety and Effectiveness of OTL78 for Detecting Prostate Cancer During Surgery
Sponsor: Clinton Bahler
ClinicalTrials ID:NCT07725523
This clinical trial is testing a new imaging agent, OTL78, to see if it can help doctors better identify cancerous tissue during prostate cancer surgery. The study aims to confirm previous findings and determine the best dose for future research.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the use of a new imaging agent called OTL78, which is a fluorescent dye that targets prostate cancer cells. The dye helps doctors see cancerous tissue more clearly during prostate surgery, especially in areas where the cancer has spread beyond the prostate. The goal is to improve the detection and removal of cancerous tissue and lymph nodes during surgery. The trial will involve up to 45 adult men with confirmed prostate cancer who are scheduled for prostate surgery and lymph node removal. Researchers aim to confirm the best dose and timing for using OTL78 to visualize cancerous tissue during these procedures.
Description
Prostate cancer is a leading cause of cancer-related deaths among men. Most prostate cancer cells have a protein called Prostate Specific Membrane Antigen (PSMA), which is present in over 90% of cases. The new imaging agent, OTL78, targets this protein and lights up under a special light, helping surgeons identify cancerous tissue during prostate surgery. This can be particularly useful for finding cancer that has spread beyond the prostate to nearby tissues and lymph nodes.
The study is open-label, meaning all participants will know they are receiving the imaging agent. It will include up to 45 men with confirmed prostate cancer who are scheduled for a standard prostate surgery with lymph node removal. The aim is to determine the best dose and timing for using OTL78 to help visualize cancerous tissue during surgery. This could potentially lead to more complete removal of cancer and reduce the chances of leaving behind cancerous tissue.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 and older.
- Have confirmed prostate cancer with specific characteristics, such as higher grade cancer or suspected spread beyond the prostate.
- Scheduled for standard prostate surgery and lymph node removal.
- Able to understand and agree to the study requirements.
- Agree to use birth control or abstain from sex during the study and for a period after.
- Have had or will have a PSMA-PET scan within 12 months of surgery for planning purposes.
Exclusion Criteria
- Surgery planned using an extraperitoneal approach.
- History of severe allergic reactions to similar imaging agents.
- Allergies to any components of the imaging agent OTL78.
- Poor kidney or liver function based on specific medical tests.
- Abnormal heart rhythm as shown on an ECG test.
- Any significant medical conditions that could affect safety or the study's goals.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Indiana University Health North Hospital | 46032 | Carmel | Indiana |
| Indiana University School of Medicine | 46202 | Indianapolis | Indiana |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.