COMPLETED

CYTALUX™for the Intraoperative Imaging of Prostate Cancer

Conditions

Prostate Cancer fluorescent image guided intervention folate laparoscopic prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.)

Official Title

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

Quick Facts

Study Start:2024-09-19

Study Completion:2025-07-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06434909

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Clinton Bahler, MD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032

United States

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Clinton Bahler, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19

Study Completion Date2025-07-24

Study Record Updates

Study Start Date2024-09-19

Study Completion Date2025-07-24

Terms related to this study

Keywords Provided by Researchers

fluorescent
image guided intervention
folate
prostate cancer
laparoscopic prostatectomy

Additional Relevant MeSH Terms

Prostate Cancer