Implantable Microdevice for the Evaluation of Drug Response in Patients with Prostate Cancer
- EX VIVO COHORT: Patients must have the ability to understand and the willingness to sign a written informed consent document
- EX VIVO COHORT: Planned radical prostatectomy for prostate cancer
- SURGICAL COHORT: Patients must have the ability to understand and the willingness to sign a written informed consent document
- SURGICAL COHORT: 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 a magnetic resonance imaging (MRI)-visible lesion concerning for prostate cancer (PCa) in the region of the positive biopsy
- SURGICAL COHORT: Participants must be evaluated by a urologic oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease
- SURGICAL COHORT: Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating surgeon
- SURGICAL COHORT: Absolute neutrophil count >= 1,500/mcL (within 30 days prior to the procedure [or within 72 hours if there has been a change in the clinical status since the initial blood draw])
- SURGICAL COHORT: Platelets >= 50,000/mcL (within 30 days prior to the procedure [or within 72 hours if there has been a change in the clinical status since the initial blood draw])
- SURGICAL COHORT: Prothrombin time (PT) (international normalized ratio [INR]) 0.8-1.2 (within 30 days prior to the procedure [or within 72 hours if there has been a change in the clinical status since the initial blood draw])
- SURGICAL COHORT: Partial thromboplastin time (PTT) within the normal range of the institution (within 30 days prior to the procedure [or within 72 hours if there has been a change in the clinical status since the initial blood draw])
- SURGICAL COHORT: 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 Brigham and Women’s Hospital (BWH)/Dana Farber Cancer Institute (DFCI), again as part of standard-of-care management
- SURGICAL COHORT: The participant’s case must be reviewed by representatives of urologic oncology and interventional radiology to assess the following factors: * Patient is clinically stable to undergo biopsy procedure(s) and surgical procedures * Patient 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
- SURGICAL COHORT: Patients 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 National Institutes of Health (NIH) central data repositories
- EX VIVO COHORT: Unwillingness to sign informed consent
- SURGICAL COHORT: 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
- SURGICAL COHORT: Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures
I. To evaluate the feasibility and safety of magnetic resonance (MR) guided microdevice placement in prostate tumors.
I. To measure local intratumor response to clinically relevant cytotoxic agents and small molecule drugs in prostate cancers using quantitative histopathologic assessment of tumor tissue.
II. To explore additional potential biomarkers of drug response, including 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.
III. To assess intratumor heterogeneity in drug response by comparing the extent of tumor response to drug among different locations in a single tumor with multiple microdevices.
IV. To describe the genetic features of the tumor tissue adjacent to the microdevice (using targeted sequencing, whole-exome sequencing, and/or whole transcriptome sequencing) and to perform a preliminary assessment of the correlation between the extent of tumor response to drug assessed by the microdevice and known genetic markers of drug response, e.g. genetic alterations in BRCA1 or BRCA2.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
EX VIVO COHORT: Patients undergo placement of microdevices to surgically removed prostate after standard of care surgery. Microdevices are then removed via MR guided imaging.
SURGERY COHORT: Patients undergo placement of 1-6 microdevices to receive standard of care drugs (abiraterone acetate, enzalutamide, carboplatin, docetaxel, doxorubicin hydrochloride, pembrolizumab, ipilimumab, and olaparib) over 48 hours. Patients then undergo standard of care surgery and retrieval of microdevices.
After completion of study treatment, patients are followed up periodically for up to 10-15 years.
Trial Phase Phase I
Trial Type Treatment
Dana-Farber Harvard Cancer Center
Adam Stuart Kibel
- Primary ID 19-599
- Secondary IDs NCI-2020-04562
- Clinicaltrials.gov ID NCT04399876