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Pilot Study of an Implantable Microdevice for Prostate Cancer

This study is testing a new way to see how prostate cancer responds to different cancer drugs. Researchers are using a small, implantable device (microdevice) that releases up to 20 FDA-approved cancer drugs directly into the prostate tumor. The goal is to see if this microdevice can safely and effectively measure how well these drugs work against prostate cancer before surgery. You may be able to join if you are a man, 22 years or older, have prostate cancer, and are scheduled for a radical prostatectomy (surgery to remove the prostate). The main goals are to see how many people have side effects and if the microdevice can be successfully placed and removed. The study is currently unclear on its recruitment status, but plans to enroll about 35 participants.

Study design
This is a pilot study, meaning it's the first time this intervention is being examined. It plans to enroll about 35 participants in total.
What's involved
Participants will have a microdevice placed in their prostate either before or after surgical removal of the prostate. The microdevice will be retrieved within 48 hours.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored from the time of microdevice placement up to 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04399876

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

Enrolling by Invitation
PHASE1Ages 22+InterventionalDiagnostic
Brigham and Women's Hospital
~35 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Microdevice

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events as defined in the CTCAE v4.0
Measured over From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
+1 more outcome measured

Conditions

Prostate Cancer
Radical Prostatectomy

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have the ability to understand and the willingness to sign a written informed consent document.
Planned radical prostatectomy for prostate cancer.
Participants must be 22 years of age or older.
Participants must have the ability to understand and the willingness to sign a written informed consent document.
Patients must have the ability to understand and the willingness to sign a written informed consent document at the study site when both the investigator and participant are at the same location, or remotely (e.g., at the participant's home or another convenient venue) where the participant reviews the consent document with the Licensed Physician Investigator over secure Zoom. The electronic consent system, Adobe, ensures the participant electronically signing the informed consent is the subject who will be participating in the research study.
Participants must present with prostate cancer falling into an intermediate or high risk category to include features: Gleason score 3+4 or higher, greater than 3 biopsy cores positive and ≥50% of 1 core positive for carcinoma, and an MRI-visible lesion concerning for PCa in the region of the positive biopsy.
Participants must be 22 years of age or older.
Participants must be evaluated by a urologic oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
Participants must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating surgeon.
Participants must have undergone multi-parametric prostate MRI that both assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care. Abnormal imaging will be correlated with the biopsy findings to maximize the likelihood of the device being put in the lesion. If the images are not adequate, the MRI scan will be repeated at BWH/DFCI, again as part of standard-of-care management.
The participant's case must be reviewed by representatives of urologic oncology and interventional radiology to assess the following factors:
Participant is clinically stable to undergo biopsy procedure(s) and surgical procedures.
Participant has sufficient volume of disease as shown by MRI to allow implantation of the microdevice.
A lesion can be selected where the microdevice is to be implanted that is a) amenable to percutaneous placement, and b) amenable to removal at the time of primary surgery
Participants must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
For men: agreement to refrain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 28 days after the last dose of ipatasertib.

Exclusion

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures.

What this trial measures

  • Number of participants with adverse events as defined in the CTCAE v4.0From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.

    Safety of microdevice placement and removal based on assessment of adverse events

  • Number of Participants with successful surgical Placement and retrieval of Microdevice48 Hours

    * 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.