Using Cytalux™ for imaging during prostate cancer surgery
An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer
This study is testing if a special imaging agent called Cytalux™ can help doctors find cancerous tissue better during prostate surgery for men with confirmed prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Indiana University Academic / other |
| Locations | 3 sites (Carmel, Indiana and 2 other locations) |
| Trial ID | NCT06434909 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of Cytalux™ (pafolacianine), a fluorescent imaging agent, in improving the detection of malignant tissue during laparoscopic radical prostatectomy and lymph node dissection in patients with biopsy-confirmed prostate cancer. The study involves up to 15 male subjects aged 18 and older, who will receive the imaging agent prior to surgery. The trial aims to assess the accuracy of this imaging technique in identifying cancerous tissues compared to standard surgical methods. Participants will undergo imaging with Near Infrared light to visualize and mark suspicious tissues during the procedure.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 and older with biopsy-confirmed prostate cancer, specifically those with Grade Group 3 to 5 and suspected extraprostatic disease or lymph node metastasis.
Not a fit: Patients with lower-grade prostate cancer or those not scheduled for laparoscopic prostatectomy and lymph node dissection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of prostate cancer surgeries, potentially leading to better patient outcomes.
How similar studies have performed: While Cytalux™ has been previously approved for use in ovarian and lung cancer surgeries, this application in prostate cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Carmel, Indiana and 2 other locations
- IU Health Joe and Shelly Schwarz Cancer Center — Carmel, Indiana, United States (Recruiting)
- Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Clinton Bahler, MD — Indiana University
- Study coordinator: Jennifer Lehman, RN
- Email: jgeck@iu.edu
- Phone: 317-278-0340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.