CYTALUX™for the Intraoperative Imaging of Prostate Cancer

Description

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

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Study Overview

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Study Details

Study overview

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.)

An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer

CYTALUX™for the Intraoperative Imaging of Prostate Cancer

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Carmel

IU Health Joe and Shelly Schwarz Cancer Center, Carmel, Indiana, United States, 46032

Indianapolis

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

Indianapolis

Indiana University Health Methodist Hospital, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Signed and dated informed consent form
  • 2. Male subjects 18 years of age and older
  • 3. Known primary prostate cancer
  • 4. Grade Group 3 to 5 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 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
  • 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Clinton Bahler, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2025-10