## Protocol Section
### Identification Module
**NCT ID:** NCT06434909

**Brief Title:** CYTALUX™for the Intraoperative Imaging of Prostate Cancer

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

#### Organization Study ID Info
**ID:** IUSCCC-0890
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2025-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** On Target Laboratories

#### Lead Sponsor

**Class:** OTHER

**Name:** Clinton Bahler

#### Responsible Party

**Investigator Affiliation:** Indiana University

**Investigator Full Name:** Clinton Bahler

**Investigator Title:** Principal investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.)

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Prostate Cancer

**Keywords:**

- fluorescent

- image guided intervention

- folate

- prostate cancer

- laparoscopic prostatectomy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with risk of EPE and having robotic prostatectomy for prostate cancer.

**Intervention Names:**

- Diagnostic Test: Cytalux™ (pafolacianine) for fluorescent imaging

**Label:** Fluorescent guided surgery

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fluorescent guided surgery

**Description:** 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.

**Name:** Cytalux™ (pafolacianine) for fluorescent imaging

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Detection of residual cancer

**Time Frame:** Day of surgery (visit 2)

#### Secondary Outcomes

**Description:** To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of

**Measure:** Treatment change

**Time Frame:** Day of surgery (visit 2)

### Eligibility Module

**Eligibility Criteria:** Inclusion 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

Exclusion Criteria:

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

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jgeck@iu.edu

**Name:** Jennifer Lehman, RN

**Phone:** 317-278-0340

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Carmel

**Contacts:**

***Contact 1:***

- **Email:** jgeck@iu.edu

- **Name:** Jennifer Lehman

- **Phone:** 317-278-0340

- **Role:** CONTACT

***Contact 2:***

- **Name:** Clinton Bahler, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** IU Health Joe and Shelly Schwarz Cancer Center

**State:** Indiana

**Zip:** 46032

**Location 2:**

**City:** Indianapolis

**Contacts:**

***Contact 1:***

- **Email:** jgeck@iu.edu

- **Name:** Jennifer Lehman

- **Phone:** 317-278-0340

- **Role:** CONTACT

***Contact 2:***

- **Name:** Clinton Bahler, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

**State:** Indiana

**Zip:** 46202

**Location 3:**

**City:** Indianapolis

**Contacts:**

***Contact 1:***

- **Email:** jgeck@iu.edu

- **Name:** Jennifer Lehman

- **Phone:** 317-278-0340

- **Role:** CONTACT

***Contact 2:***

- **Name:** Clinton Bahler, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Indiana University Health Methodist Hospital

**State:** Indiana

**Zip:** 46202

#### Overall Officials

**Official 1:**

**Affiliation:** Indiana University

**Name:** Clinton Bahler, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

- ID: T399

- Name: Indole

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
