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

Enrolling

Trial ID:NCT04399876

View complete trial on ClinicalTrials.gov

Protocol #:19-599

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer, Radical Prostatectomy

Phase:Feasibility / Pilot

Principal Investigator:Kibel, Adam

Site Investigator(s):Jonas, Oliver,

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
- 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).

Protocol #: 19-599

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)