CYTALUX™for the Intraoperative Imaging of Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.)

Key facts

Study ID

NCT06434909

Run by

Indiana University

People needed

9

Starts

2024-09-19

Expected to finish

2025-09-04

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• The surgeon plans to perform an extraperitoneal approach
• 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

Where it is running

• IU Health Joe and Shelly Schwarz Cancer Center — Carmel, Indiana, United States
• Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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