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Completed

NCT Number: NCT05946603

IS-002 Phase 2 Prostate Cancer Study

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

UCSF, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 18 to 75.
  • Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.
  • 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.
  • 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.
  • Subject is willing and able to provide written informed consent.
  • Subject can comply with the study procedures and study visits and understands an informed consent document.

Exclusion criteria

  • Subject has known bone metastasis.
  • Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • 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
  • Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.
  • 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.
  • 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.

Treatment and study plan

Administration of IS-002

Drug

Intravenous administration of IS-002 approximately 24 hours prior to surgery

Firefly fluorescent imaging

Device

Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002

robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Procedure

Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Other names: RARP

Primary outcomes

  1. The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.

    Time frame: Within 3 months post-surgery

    The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.

  2. The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.

    Time frame: Within 3 months post-surgery

    The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.

Secondary outcomes

  1. Diagnostic performance of IS-002 fluorescence

    Time frame: Up to 1 year post-surgery

    The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.

  2. Safety: Adverse event assessment

    Time frame: Up to 1 year post-surgery

    Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0

  3. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: Up to 24 hours post-IS-002 administration

    Area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration as calculated by linear up/log down trapezoidal method (AUC0-last)

  4. Time to biochemical recurrence (BCR)

    Time frame: Up to 1 year post-surgery

    Time to BCR in the Intervention arm and the Control arm. BCR is defined a PSA level >0.1 ng/mL as determined by an ultrasensitive PSA assay.

  5. Time to secondary treatment initiation

    Time frame: Up to 1 year post-surgery

    Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.

  6. Number of intraoperative fluorescent lymph nodes that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only

    Time frame: Up to 3 months post surgery

    In the Intervention arm, the number of intraoperative fluorescent lymph nodes, per subject and per lymph node basin, that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 14, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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