A Phase 1 interventional study of Microdevice in Prostate Cancer and Radical Prostatectomy, sponsored by Brigham and Women's Hospital. Enrolling by invitation at 1 site in United States. Open to male participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Brigham and Women's Hospital · Phase 1, Interventional, and Diagnostic
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
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:
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 35 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility Criteria: Ex Vivo Cohort
Inclusion Criteria
Eligibility Criteria: Surgical Cohort
Inclusion Criteria
The participant's case must be reviewed by representatives of urologic oncology and interventional radiology to assess the following factors:
Exclusion Criteria
Participant eligibility for intervention and selection of lesion for device placement \- Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor(s) prior to surgery. The microdevice in the surgery cohort will dwell in the tumor tissue for approximately 48 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Placement of at least 1, and up to 6, microdevices depending on the number of lesions, size and accessibility * Extirpative surgery will proceed according to standard-of-care procedures. The microdevice(s) will be removed surgically along with surrounding tumor tissue. * Standard of care treatment and follow-up of clinical course
Combination Product: Microdevice
Each participant will undergo a screening process to determine their eligibility for microdevice placement, consisting of the following items: * Routine standard of care for radical prostatectomy. * Placement of implantable microdevice with multiple miniature drug reservoirs but no drug in prostate that have been removed * Ex vivo image guided removal using retrieval device * Standard of Care Treatment and follow-up of clinical course
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
Number of participants with adverse events as defined in the CTCAE v4.0
Safety of microdevice placement and removal based on assessment of adverse events
Time frame: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
Number of Participants with successful surgical Placement and retrieval of Microdevice
* Feasibility of microdevice placement based on the ability in the Surgical Cohort to percutaneously place and surgically retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation. * In the Surgical Cohort, if not more than 1 IMD per patient fails to be percutaneously placed and surgically retrieved with sufficient tissue of sufficient quality for downstream histopathology analysis and interpretation, we would consider this procedure to be a success. If at least 23/30 Surgical Cohort patients have successful procedures, as previously defined, we would consider this approach feasible. The 90% CI for 23 out of 30 successes is (60.6%, 88.5%) and thus excluding a 60% success rate which is considered as too low.
Time frame: 48 Hours
Local intratumor response
measure local intratumor response to clinically relevant cytotoxic agents and small molecule drugs in prostate cancers using quantitative histopathologic assessment of tumor tissue. All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates. Descriptive statistics will be used to summarize the quantitative measurements of apoptosis, proliferation, DNA repair, etc. for drug-treated regions compared to vehicle-treated regions. At least two separate regions will contain vehicle to account for tumor heterogeneity.
Time frame: 48 Hours
Intratumor heterogeneity in drug response
comparing the extent of tumor response to drug among different locations in a single tumor with multiple microdevice. All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.
Time frame: 48 Hours
Biomarkers of drug response
immune infiltrates, in the local tumor tissue adjacent to the microdevice, and to perform a preliminary assessment of the correlation between these features and extent of tumor response with the microdevice All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.
Time frame: 48 Hours
Genetic features of the tumor tissue
To determine the genetic features of the tumor tissue adjacent to the microdevice (e.g. whole exome sequencing, whole transcriptome sequencing) and to perform a preliminary assessment of the correlation between known genetic markers of drug sensitivity or resistance and extent of tumor response with the microdevice Genetic alterations will be catalogued in terms of single nucleotide variants, insertions/deletions, and copy number changes and will be primarily reported in a descriptive manner. Preliminary correlations between a specific genetic feature and specific clinical features will be tested using the Chi-squared/Fisher's exact test for categorical variables or the T-test or Wilcoxon Rank-Sum test for continuous variables
Time frame: 48 Hours
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf
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