Clinical trial NCT04399876: Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer
Official title: Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Prostate Cancer
Radical Prostatectomy
Keywords: Prostate Cancer
Radical Prostatectomy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-05-22
Enrollment: 35
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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.

Eligibility criteria: 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 study.
  * 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 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.
  * 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.

Primary outcomes:
measure: Number of participants with adverse events as defined in the CTCAE v4.0
timeFrame: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
measure: Number of Participants with successful surgical Placement and retrieval of Microdevice
timeFrame: 48 Hours
Secondary outcomes:
measure: Local intratumor response
timeFrame: 48 Hours
measure: Intratumor heterogeneity in drug response
timeFrame: 48 Hours
measure: Biomarkers of drug response
timeFrame: 48 Hours
measure: Genetic features of the tumor tissue
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Adam S Kibel, MD
role: PRINCIPAL_INVESTIGATOR
References: