IS-002 in Prostate Cancer

Overview

About this study

The purpose of this study is to investigate positive surgical margins (PSMs) in subjects undergoing RALP with (e)PLND after intravenous (IV) IS-002 administration with (Intervention arm) and without (Control arm) intraoperative near-infrared (NIR) fluorescence imaging.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Subjects aged 18 to 75.

2. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.

3. Subject has CAPRA ≥ 6; or ≥ T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score ≥ 8; or regional lymphadenopathy suspicious for nodal metastases on imaging.

4. Subject is scheduled to undergo robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using a da Vinci® X/Xi Surgical
System equipped with Firefly® Fluorescence Imaging.

5. Subject is willing and able to provide written informed consent.

6. Subject can comply with the study procedures and study visits and understands an informed consent document.

Exclusion Criteria:

1. Subject has known bone metastasis.

2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

3. Subject has a known history of acute or chronic liver or kidney disease.

  • Renal function at screening:
  • Creatinine clearance: < 50 mL/min as determined using the Cockcroft-Gault formula; 
  • Albumin: < LLN;
  • Hepatic function at screening: AST and/or ALT: > 2.5 x ULN;
  • Total Bilirubin (serum): >1.5 x ULN.

4. Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.

5. Subject is currently receiving an investigational therapeutic agent; or has participated in a study of an investigational therapeutic agent within the past 6 months prior to the day of IS-002 infusion; or is involved in a significant risk
investigational device study within the past 6 months prior to the day of IS-002 infusion.

6. Subject has any other condition or personal circumstance that, in the judgment of the site Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/28/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Tollefson, M.D.

Open for enrollment

Contact information:

Kathryn Barthels

(507) 538-5772

Barthels.Kathryn@mayo.edu

More information

Publications

Publications are currently not available