NCT04399876

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is assessing the feasibility and safety of implanting and retrieving a 'microdevice' that releases up to 20 drugs directly within the prostate cancer lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against prostate cancer. Participants will be identified with confirmed prostate cancer whose treatment plan includes surgery as a component of standard-of-care treatment. The name of the study intervention involved in this study is: * Implantation of a MR-guided microdevice . * It is expected that about 35 people will take part in this research study; 5 in the Ex Vivo Cohort and 30 in Surgery Cohort. * Ex Vivo Cohort will undergo placement of microdevice in the prostate after its surgical removal. * Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor prior to surgery. This research study is a Pilot Study, which is the first-time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved the implantation of the microdevice for this specific disease, but usage of this has been approved for other uses.

Conditions

• Prostate Cancer
• Radical Prostatectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-22
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2020-05-22
• Last updated: 2023-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study