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

Protocol # :
Prostate Cancer
Radical Prostatectomy
Feasibility / Pilot
Disease Sites
Principal Investigator
Kibel, Adam

Trial Description

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

Eligibility Requirements

Eligibility Criteria: Ex Vivo Cohort

- Inclusion Criteria

- 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.

- Exclusion Criteria -- Unwillingness to sign informed consent.

Eligibility Criteria: Surgical Cohort

- Inclusion Criteria

- 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

- 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

- 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

- 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 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.