Clinical Trials /

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

NCT04399876

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 19-599
  • SECONDARY ID: R01CA232174
  • NCT ID: NCT04399876

Conditions

  • Prostate Cancer
  • Radical Prostatectomy

Purpose

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.

      Patients 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.
    

Trial Arms

NameTypeDescriptionInterventions
Surgery CohortExperimentalPatient eligibility for intervention and selection of lesion for device placement - Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor(s) prior to surgery. The microdevice in the surgery cohort will dwell in the tumor tissue for approximately 48 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Placement of at least 1, and up to 6, microdevices depending on the number of lesions, size and accessibility Extirpative surgery will proceed according to standard-of-care procedures. The microdevice(s) will be removed surgically along with surrounding tumor tissue. Standard of care treatment and follow-up of clinical course
    Ex-Vivo CohortExperimentalEach participant will undergo a screening process to determine their eligibility for microdevice placement, consisting of the following items: Routine standard of care for radical prostatectomy. Placement of implantable microdevice with multiple miniature drug reservoirs but no drug in prostate that have been removed Ex vivo image guided removal using retrieval device Standard of Care Treatment and follow-up of clinical course

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Eligibility Criteria for Ex Vivo Cohort
      
                     -  Patients 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
      
                     -  Patients 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.
      
                     -  Patients 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). Patients 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:
      
                          -  Patient is clinically stable to undergo biopsy procedure(s) and surgical
                             procedures
      
                          -  Patient 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 3.3.9 Patients 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:
      
                -  Exclusion Criteria for Ex Vivo Cohort
      
                   -- Unwillingness to sign informed consent
      
                -  Exclusion Criteria for Surgical Cohort
      
                     -  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).
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:22 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Number of participants with adverse events as defined in the CTCAE v4.0
      Time Frame:From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
      Safety Issue:
      Description:Safety of microdevice placement and removal based on assessment of adverse events

      Secondary Outcome Measures

      Measure:Local intratumor response
      Time Frame:48 Hours
      Safety Issue:
      Description:measure local intratumor response to clinically relevant cytotoxic agents and small molecule drugs in prostate cancers using quantitative histopathologic assessment of tumor tissue. All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates. Descriptive statistics will be used to summarize the quantitative measurements of apoptosis, proliferation, DNA repair, etc. for drug-treated regions compared to vehicle-treated regions. At least two separate regions will contain vehicle to account for tumor heterogeneity.
      Measure:Intratumor heterogeneity in drug response
      Time Frame:48 Hours
      Safety Issue:
      Description:comparing the extent of tumor response to drug among different locations in a single tumor with multiple microdevice. All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.
      Measure:Biomarkers of drug response
      Time Frame:48 Hours
      Safety Issue:
      Description:immune infiltrates, in the local tumor tissue adjacent to the microdevice, and to perform a preliminary assessment of the correlation between these features and extent of tumor response with the microdevice All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.
      Measure:Genetic features of the tumor tissue
      Time Frame:48 Hours
      Safety Issue:
      Description:To determine the genetic features of the tumor tissue adjacent to the microdevice (e.g. whole exome sequencing, whole transcriptome sequencing) and to perform a preliminary assessment of the correlation between known genetic markers of drug sensitivity or resistance and extent of tumor response with the microdevice Genetic alterations will be catalogued in terms of single nucleotide variants, insertions/deletions, and copy number changes and will be primarily reported in a descriptive manner. Preliminary correlations between a specific genetic feature and specific clinical features will be tested using the Chi-squared/Fisher's exact test for categorical variables or the T-test or Wilcoxon Rank-Sum test for continuous variables

      Details

      Phase:Phase 1
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Dana-Farber Cancer Institute

      Trial Keywords

      • Prostate Cancer
      • Radical Prostatectomy

      Last Updated

      May 19, 2020