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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2026
  • participants needed
    35
  • sponsor
    Dana-Farber Cancer Institute
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Updated on 5 August 2020
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neutrophil count
carcinoma
prostatectomy

Summary

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

Description

This research study is assessing the feasibility and safety of implanting and retrieving a 'microdevice' that releases up to 20 drugs directly within the prostate cancer lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against prostate cancer.

Participants will be identified with confirmed prostate cancer whose treatment plan includes surgery as a component of standard-of-care treatment.

The name of the study intervention involved in this study is:

  • Implantation of a MR-guided microdevice .
  • It is expected that about 35 people will take part in this research study; 5 in the Ex Vivo Cohort and 30 in Surgery Cohort.
  • Ex Vivo Cohort will undergo placement of microdevice in the prostate after its surgical removal.
  • Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor prior to surgery.

This research study is a Pilot Study, which is the first-time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved the implantation of the microdevice for this specific disease, but usage of this has been approved for other uses.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Radical Prostatectomy
Age 22years - 100years
Treatment Microdevice
Clinical Study IdentifierNCT04399876
SponsorDana-Farber Cancer Institute
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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)
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