Evidence map›Paper›PMID 39348711›Full record

ArticleThe Journal of urology2025

Novel Intraprostatic Magnetic Resonance-Guided Implantation of Multidrug-Eluting Microdevice for Testing of Systemic Therapy Agents In Situ: Proof of Concept in Intermediate-Risk and High-Risk Prostate Cancer.

Benjamin V Stone, Christine A Dominas, Sharath K Bhagavatula, Sebastian W Ahn, Zuzana Tatarova, Juraj Jakubik, Destiny Matthew, Matthew Mossanen, Daniella Furtado, Kemal Tuncali and 5 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04399876 (Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04399876 phase1enrolling by invitationnot on this map

Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer

TypeinterventionalSponsorBrigham and Women's HospitalRan2020 to 2027Enrolled35ConditionsProstate Cancer, Radical ProstatectomyArmsMicrodevice
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Benjamin V StoneDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Christine A DominasDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Sharath K BhagavatulaDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Sebastian W AhnDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Zuzana TatarovaDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Juraj JakubikDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Destiny MatthewDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Matthew MossanenDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Daniella FurtadoDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Kemal TuncaliDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Michelle S HirschDepartment of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Nobuhiko HataDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Clare TempanyDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Oliver JonasDepartment of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Adam S KibelDepartment of Urology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Funding

TRD 3 - Enabling Technologies for Intraprocedural GuidanceP41EB028741 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI Nobuhiko Hata, CLARE M TEMPANY · 2021 to 2026
$10.7M
Pilot study of an implantable microdevice to test multiple drug responses in prostate cancer patientsR01CA232174 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI HATA, NOBUHIKO, JONAS, OLIVER · 2019 to 2023
$3.4M
Physician Assistance Technology in Image-guided Robotic Intervention of ProstateR01EB030539 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI HATA, NOBUHIKO, ZHANG, HAICHONG · 2021 to 2024
$2.7M
Implantable microdevices with integrated optical imaging for high-throughput in situ tumor response and drug sensitivity measurementR37CA224144 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI JONAS, OLIVER · 2018 to 2023
$2.4M
NCI NIH HHS R01 CA232174NCI NIH HHS R37 CA224144NIBIB NIH HHS P41 EB028741NIBIB NIH HHS R01 EB030539
6 · The paper itself

Abstract

purposeThe purpose of this study was to assess safety and feasibility of percutaneous magnetic resonance-guided placement of an implantable microdevice (IMD) to evaluate in situ intratumor response to multiple pharmacologic agents in men with intermediate-risk and high-risk localized prostate cancer. MATERIALS AND

methodsBiocompatible IMDs measuring 750 µm in diameter and 5 mm in length were prepared with 20 reservoirs containing candidate drug and drug combinations including second-generation androgen inhibitors, PARP inhibitors, PD-1 inhibitors, and conventional chemotherapy. Men with intermediate-risk or high-risk localized prostate cancer and MRI-visible lesions were enrolled. Up to 4 IMDs were placed using a transperineal approach into MRI-visible tumors 2 days before planned radical prostatectomy. After radical prostatectomy, the IMDs and a small segment of surrounding tumor tissue were removed and sectioned, stained, and analyzed for tissue drug response by a variety of pharmacodynamic markers.

resultsFourteen patients were enrolled: 7 (50%) with intermediate-risk and 7 (50%) with high-risk localized prostate cancer. A total of 53 IMDs were implanted (mean 3.8 per patient), and 49 IMDs (92%) were successfully retrieved. All men underwent uncomplicated robotic-assisted radical prostatectomy and bilateral pelvic lymph node dissection 2 days after IMD placement. There were no severe adverse events. Pathological examination of the tissues adjacent to the IMDs demonstrated differential drug response within patients and between patients. Limitations include small sample size.

conclusionsA multidrug IMD can be safely placed percutaneously into MRI-visible lesions before radical prostatectomy, enabling assessment of tumor-specific local response to multiple agents simultaneously within the tumor's normal stromal environment to guide targeted systemic therapy.

trial registrationClinicalTrials.gov identifier: NCT04399876.

Indexed as

Prostatic NeoplasmsAgedAntineoplastic AgentsFeasibility StudiesHumansMagnetic Resonance ImagingMagnetic Resonance Imaging, InterventionalMaleMiddle AgedProof of Concept StudyProstatectomyAntineoplastic Agentsprecision oncologyprostate cancer

Identifiers

PMID39348711
PMCPMC11717626

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Registered trials

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.