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Cytalux™ for Prostate Cancer

Phase 2
Recruiting
Led By Clinton Bahler, MD
Research Sponsored by Clinton Bahler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male subjects 18 years of age and older
Known primary prostate cancer with Grade Group 3 to 5 and suspected extraprostatic disease (EPD) or lymph node metastasis, or both
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery (visit 2)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using Cytalux™ with Near InfraRed imaging can help find cancerous tissue better during prostate cancer surgery. The imaging agent has already been approved for use in

Who is the study for?
This trial is for adults with biopsy-confirmed prostate cancer who are undergoing prostatectomy and lymph node dissection. Details about specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.
What is being tested?
The trial is testing Cytalux™ (pafolacianine) used alongside NIR fluorescent imaging to see if it helps better identify cancerous tissue during surgery in patients with prostate cancer. The FDA has previously approved this agent for ovarian and lung cancer surgeries.
What are the potential side effects?
Specific side effects of Cytalux™ (pafolacianine) are not listed here, but generally, imaging agents can cause allergic reactions, skin rashes or irritation at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
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My prostate cancer is aggressive and may have spread beyond the prostate.
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I am scheduled for a minimally invasive prostate surgery with possible lymph node removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery (visit 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery (visit 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Detection of residual cancer
Secondary study objectives
Treatment change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fluorescent guided surgeryExperimental Treatment1 Intervention
Patients with risk of EPE and having robotic prostatectomy for prostate cancer.

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Who is running the clinical trial?

Clinton BahlerLead Sponsor
1 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Prostate Cancer
51 Patients Enrolled for Prostate Cancer
On Target LaboratoriesUNKNOWN
1 Previous Clinical Trials
10 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,037 Previous Clinical Trials
1,218,958 Total Patients Enrolled
8 Trials studying Prostate Cancer
638 Patients Enrolled for Prostate Cancer
~9 spots leftby Mar 2025
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