Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04399876 |
Recruitment Status :
Enrolling by invitation
First Posted : May 22, 2020
Last Update Posted : December 14, 2023
|
Tracking Information | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 19, 2020 | ||||||||||||||
First Posted Date ICMJE | May 22, 2020 | ||||||||||||||
Last Update Posted Date | December 14, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | June 22, 2020 | ||||||||||||||
Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer | ||||||||||||||
Official Title ICMJE | Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer | ||||||||||||||
Brief 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:
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 Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||||||||
Condition ICMJE |
|
||||||||||||||
Intervention ICMJE | 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 |
||||||||||||||
Study Arms ICMJE |
|
||||||||||||||
Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||
Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Enrolling by invitation | ||||||||||||||
Estimated Enrollment ICMJE |
35 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | March 1, 2026 | ||||||||||||||
Estimated Primary Completion Date | March 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Eligibility Criteria: Ex Vivo Cohort
Eligibility Criteria: Surgical Cohort
|
||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||
Ages ICMJE | 22 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04399876 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-599 R01CA232174 ( U.S. NIH Grant/Contract ) |
||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||
Current Responsible Party | Oliver Jonas, Brigham and Women's Hospital | ||||||||||||||
Original Responsible Party | Adam Kibel, MD, Brigham and Women's Hospital, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||||||||
Original Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||||
Investigators ICMJE |
|
||||||||||||||
PRS Account | Brigham and Women's Hospital | ||||||||||||||
Verification Date | December 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |