Pilot study of an implantable microdevice for evaluating drug responses in situ in prostate cancer

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

Inclusion Criteria:

- Eligibility Criteria Ex Vivo Cohort

- 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.

- Eligibility Criteria for Surgical Cohort

- Participants must have the ability to understand and the willingness to sign a
written informed consent document.

- 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 will undergo laboratory testing 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). Participants must have absolute neutrophil count
≥1,500/mcL, platelets ≥50,000/mcL, PT (INR) 0.8-1.2 and PTT within the normal
range of the institution.

- 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.

- Exclusion Criteria:

- 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 (detailed below).