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

NCT04399876 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-18

No results posted yet for this study

Summary

In this research study, is assessing the feasibility of using an MR-guided implantable microdevice to measure tumor response to chemotherapy and other clinically relevant drugs in participants that have prostate cancer and are scheduled for a radical prostatectomy.

The name of the study intervention involved in this study is:

\- Implantation of a MR-guided microdevice

Conditions

Interventions

COMBINATION_PRODUCT

Microdevice

Surgery Cohort: Placement of 1-6 microdevices: Drugs chosen have all been FDA approved for the treatment of cancer (so therefore safe) and there are phase 2 or 3 data that the drug has efficacy in prostate cancer. Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations Ex vivo Cohort: Placement of multiple microdevices with miniature drug reservoirs but no drug is loaded into the removed prostate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Adam S Kibel, MD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2027-08-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399876 on ClinicalTrials.gov