Evidence map›Paper›PMID 37516587›Full record

ArticleEuropean urology oncology2024

First-in-human Evaluation of a Prostate-specific Membrane Antigen-targeted Near-infrared Fluorescent Small Molecule for Fluorescence-based Identification of Prostate Cancer in Patients with High-risk Prostate Cancer Undergoing Robotic-assisted Prostatectomy.

Hao G Nguyen, Nynke S van den Berg, Alexander L Antaris, Lingru Xue, Scott Greenberg, J Walker Rosenthal, Anna Muchnik, Alwin Klaassen, Jeffry P Simko, Sanjeev Dutta and 3 more

Open access · hybridAbstract read
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In one paragraph

Article in European urology oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
8.5field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 33 citations in OpenAlex.

  1. More Than a Glow: How Cyanine Dyes Shape Tracer Pharmacokinetics.Angewandte Chemie (International ed. in English) · 2026
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  5. [European journal of nuclear medicine and molecular imaging · 2026
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  17. Article
  18. Article
  19. Article
  20. Current clinical applications of Cerenkov luminescence for intraoperative molecular imaging.European journal of nuclear medicine and molecular imaging · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Hao G NguyenDepartment of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
Nynke S van den BergIntuitive Surgical, Sunnyvale, CA, USA.
Alexander L AntarisIntuitive Surgical, Sunnyvale, CA, USA.
Lingru XueDepartment of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
Scott GreenbergDepartment of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
J Walker RosenthalIntuitive Surgical, Sunnyvale, CA, USA.
Anna MuchnikIntuitive Surgical, Sunnyvale, CA, USA.
Alwin KlaassenIntuitive Surgical, Sunnyvale, CA, USA.
Jeffry P SimkoDepartment of Pathology, University of California, San Francisco, CA, USA.
Sanjeev DuttaIntuitive Surgical, Sunnyvale, CA, USA.
Jonathan M SorgerIntuitive Surgical, Sunnyvale, CA, USA.
Pamela MunsterDepartment of Medicine, Phase 1 Clinic, University of California, San Francisco, CA, USA.
Peter R CarrollDepartment of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA. Electronic address: peter.carroll@ucsf.edu.
Intuitive Surgical (United States) · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMen with high-risk prostate cancer undergoing surgery likely recur due to failure to completely excise regional and/or local disease.

objectiveThe first-in-human evaluation of safety, pharmacokinetics, and exploratory efficacy of IS-002, a novel near-infrared prostate-specific membrane antigen (PSMA)-targeted fluorescence imaging agent, designed for intraoperative prostate cancer visualization. DESIGN, SETTING, AND

participantsA phase 1, single-center, dose-escalation study was conducted in 24 men with high-risk prostate cancer scheduled for robotic-assisted radical prostatectomy with (extended) pelvic lymph node dissection using the da Vinci surgical system. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Adverse events (AEs), vital signs, complete blood count, complete metabolic panel, urinalysis, and electrocardiogram were assessed over a 14-d period and compared with baseline. The pharmacokinetic profile of IS-002 was determined. Diagnostic accuracy was assessed for exploratory efficacy. RESULTS AND LIMITATIONS: AEs predominantly included discoloration of urine (n = 22/24; expected, related, grade 1). There were no grade ≥2 AEs. IS-002 C

conclusionsIS-002 is safe and well tolerated, and has the potential to enable intraoperative tumor detection that could not be identified using standard imaging. PATIENT SUMMARY: IS-002 is a new imaging agent that specifically targets the prostate-specific membrane antigen receptor. In this study, we tested IS-002 for the first time in men with high-risk prostate cancer undergoing surgery and found that IS-002 is safe, is cleared from the body quickly, and potentially allows identification of prostate cancer in areas that would not be identified by conventional white light imaging.

Indexed as

Prostatic NeoplasmsRobotic Surgical ProceduresHumansMaleNeoplasm Recurrence, LocalProstateProstatectomyFluorescence imagingImage-guided surgeryMinimally invasive surgeryProstate cancerProstate-specific membrane antigenRobotic surgery

Identifiers

PMID37516587
OpenAlexW4385323327

What OpenQuestion holds

Textmetadata
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.