Clinical trial · Interventional
CYTALUX™for the Intraoperative Imaging of Prostate Cancer
An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer. The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytalux™ (pafolacianine) for fluorescent imaging | Drug | — | UNRESOLVED |
| Image Guided Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pafolacianine injection and surgery
- interventionNames
- Drug: Cytalux™ (pafolacianine) for fluorescent imaging
- Procedure: Image Guided Surgery
Primary outcomes (1)
- measure
- Detection of residual cancer
- timeFrame
- Day of surgery (visit 2)
- description
- The proportion of subjects who have a Clinically Significant Event (CSE). A CSE is a composite endpoint defined as at least one of the following outcomes: 1. One or more resected "NIR only" positive lymph nodes that contain metastatic disease as confirmed by pathology. 2. Histologically confirmed cancer in resected "NIR only" residual non-nodal soft tissue following prostatectomy.
Secondary outcomes (2)
- measure
- Treatment change
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available