NCT06434909CompletedPhase 2
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 · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 17 May 2024
- Start date
- 19 Sept 2024
- Primary completion date
- 4 Sept 2025
- Lead sponsor
- Indiana University
- Diseases
- Prostate cancer
- NCT number
- NCT06434909
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 9
- From 19 Sept 2024 to the primary completion date, 4 Sept 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of PAFOLACIANINE
Other
- The surgeon plans to perform an extraperitoneal approach
Who the study is looking for
- Signed and dated informed consent form and HIPAA form
- Male subjects 18 years of age and older
- Known primary prostate cancer
- Grade Group 3 to 5 (≥cT3) with either:
- suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or 3 or more biopsy cores of grade group 3-5;
- suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
- or both.
- Planned to undergo a standard of care laparoscopic prostatectomy with or without robotic assistance, and lymph node dissection
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- Agree to stop folate or folic acid supplements at least 48 hours prior to injection of study agent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Indiana University Health Methodist Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.