A Phase 2 interventional study of Cytalux™ (pafolacianine) for fluorescent imaging and Image Guided Surgery in Prostate Cancer, sponsored by Indiana University. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Indiana University · Phase 2, Interventional, and Diagnostic
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.)
This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer (PCa) who have been scheduled to undergo a laparoscopic radical prostatectomy with or without robotic assistance, with pelvic lymph node dissection. This is a non-intervention trial to assess the accuracy of an imaging agent, folate targeted fluorescent dye (pafolacianine), during a standard of care radical prostatectomy.
Qualifying subjects will be Grade Group 3 to 5 (>/= cT3) with either suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+).
Whether using an anterior or a posterior approach, the tissues planned for removal will be visualized first under normal light, and their locations marked on a provided template. All additional suspicious tissue or nodes will be similarly marked, whether removed or not. Prior to removal, the field must be illuminated with Near Infrared light (NIR) and fluorescent tissues must be marked on the template. This may proceed in an iterative fashion, switching from first normal light to NIR as the surgical field expands.
NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following IV infusion of pafolacianine. Lymphatics to be examined are, at a minimum, the external iliac, internal iliac and obturator fossa, and common iliac. Fluorescence positive nodules and nodes will be removed at the surgeon's discretion and sent as labeled (specimen number, tissue, location) specimens to pathology without designation of florescence. Ink dots should ideally be applied to the spot suspected of being cancerous.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 9 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Grade Group 3 to 5 (≥cT3) with either:
Exclusion Criteria:
Drug: Cytalux™ (pafolacianine) for fluorescent imaging · Procedure: Image Guided Surgery
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.
prostatectomy using appropriate imaging system
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.
Time frame: Day of surgery (visit 2)
Treatment change
To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of PAFOLACIANINE with NIR imaging.
Time frame: Day of surgery (visit 2)
Differences in sensitivity and specificity of lesions
T evaluate proportion of lesions that are either: fluorescence positive, and prostate cancer positive; fluorescence positive but cancer negative; fluorescence negative but cancer positive; or, fluorescence negative and cancer negative.
Time frame: Day of surgery (visit 2)
Plan to share: No
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