for males ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
completion around



Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.

Official Title

Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescence Imaging


Prostate Cancer, Prostatic Neoplasms, Fluorophosphate, Administration of IS-002, Firefly fluorescent imaging, robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection, RARP + IS-002, RARP + IS-002 + intraoperative near-infrared imaging


You can join if…

Open to males ages 18-75

  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.

You CAN'T join if...

  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: i. Creatinine clearance: <50 mL/min as determined using the Cockcroft-Gault formula ii. Albumin: <LLN

    • Hepatic function at screening: i. AST and/or ALT: >2.5x ULN ii. Total Bilirubin (serum): >1.5x 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.


  • UCSF accepting new patients by invitation only
    San Francisco California 94158 United States
  • Mayo Clinic accepting new patients
    Rochester Minnesota 55905 United States
  • Johns Hopkins accepting new patients
    Baltimore Maryland 21287 United States
  • MSKCC accepting new patients
    New York New York 10065 United States


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Intuitive Surgical
Phase 2 Prostate Cancer Research Study
Study Type
Expecting 60 study participants
Last Updated