CYTALUX™for the Intraoperative Imaging of Prostate Cancer

Launched by INDIANA UNIVERSITY · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging agent called Cytalux™ (pafolacianine) to see if it helps doctors find prostate cancer more effectively during surgery. The aim is to improve the detection of cancerous tissue in men who are having surgery for prostate cancer and possibly removing lymph nodes. Cytalux™ works by highlighting cancer cells using a special type of light, making them easier to see during the operation.

To be eligible for this trial, participants need to be men aged 18 or older who have been diagnosed with prostate cancer and are planning to have surgery. They should have a more aggressive type of cancer, which means it is likely to grow quickly or spread. Participants will undergo a laparoscopic surgery, where small incisions are made, and they will need to follow some guidelines before the study, like stopping certain supplements. If you decide to join this study, you can expect to work closely with your healthcare team and help contribute to important research that could improve cancer treatment in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent form and HIPAA form
• • 2. Male subjects 18 years of age and older
• • 3. Known primary prostate cancer
• 4. Grade Group 3 to 5 (≥cT3) with either:
• • 1. suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or 3 or more biopsy cores of grade group 3-5;
• • 2. suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
• • 3. or both.
• • 5. Planned to undergo a standard of care laparoscopic prostatectomy with or without robotic assistance, and lymph node dissection
• • 6. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
• • 7. Agree to stop folate or folic acid supplements at least 48 hours prior to injection of study agent
• Exclusion Criteria:
• • 1. The surgeon plans to perform an extraperitoneal approach
• • 2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
• • 3. History of anaphylactic reactions to products containing indocyanine green
• • 4. History of allergy to any of the components of PAFOLACIANINE

Trial Officials