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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04399876
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Enrolling by invitation
Phase Phase 1
Start date June 22, 2020
Completion date March 1, 2026

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