CYTALUX™for the Intraoperative Imaging of Prostate Cancer

NCT06434909 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IUSCCC-0890
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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

Prostate Cancer

Keywords

fluorescent; image guided intervention; folate; prostate cancer; laparoscopic prostatectomy

Outcome Measures

Primary Outcomes (1)

• Detection of residual cancer

  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.

  Day of surgery (visit 2)

Secondary Outcomes (2)

• Treatment change

  Day of surgery (visit 2)

• Differences in sensitivity and specificity of lesions

  Day of surgery (visit 2)

Study Arms (1)

Pafolacianine injection and surgery

EXPERIMENTAL

Drug: Cytalux™ (pafolacianine) for fluorescent imaging; Procedure: Image Guided Surgery

Interventions

Cytalux™ (pafolacianine) for fluorescent imaging DRUG

Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye for real-time cancer margin status. This is used in conjunction with appropriate imaging system.

Pafolacianine injection and surgery

Image Guided Surgery PROCEDURE

prostatectomy using appropriate imaging system

Pafolacianine injection and surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead
• On Target Laboratories, LLC: collaborator

Study Sites (3)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

Location

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pafolacianine; Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Clinton Bahler, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 30, 2024
• Study Start: September 19, 2024
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)