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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04399876
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
MALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microdevice — COMBINATION_PRODUCT
    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 Details

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

Key Dates

Start date
Jun 22, 2020
Status verified
May 2026
Primary completion
Aug 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Surgery Cohort
    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
  • Experimental: Ex-Vivo Cohort
    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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Brigham and Women's Hospital· Boston, MA

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