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Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

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ClinicalTrials.gov Identifier: NCT02681614
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

This clinical research study tests the Uronav system. Patients with prostate cancer will be asked to take part in this study.

Uronav system is an investigational device that is used on this study to help place markers in the patient. These are called fiducial markers and they are placed in the patient to help plan radiation treatment. Radiation therapy treatment will be planned by the treating physician and will not be experimental or part of this research study.

This study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI).


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Uronav guided biopsy Device: Magnetic resonance imaging Not Applicable

Detailed Description:

Study Objectives

Specific Aim 1: Evaluate final pathology post-operatively for histopathology confirmation of multiparametric MRI targets detected during treatment planning. This will be accomplished by using transperineal biopsies obtained prior to interstitial brachytherapy during the procedure, while under anesthetic just prior to the placement of the brachytherapy needles and sources.

Specific Aim 2: Evaluate the ability of the Uronav system in a transperineal setting to guide biopsy needle placement using the electromagnetic guidance system and transperineal ultrasound probe stabilization device and stepper.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
Actual Study Start Date : July 21, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Uronav

Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation

o All biopsies will be completed in the outpatient setting in the ambulatory OR prior to routine prostate brachytherapy under general anesthesia.

Device: Uronav guided biopsy
All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia. Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum.
Other Name: Phillips Medical's Uronav

Device: Magnetic resonance imaging
An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study.
Other Name: MRI




Primary Outcome Measures :
  1. Number of biopsies with true positives between biopsy tissue and intraprostatic MRI [ Time Frame: Within 15 days of screening ]
    Report the sensitivity of the intraprostatic MRI

  2. Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI [ Time Frame: Within 15 days of screening ]
    Report the specificity of the intraprostatic MRI

  3. Number of biopsies with false positives between biopsy tissue and intraprostatic MRI [ Time Frame: Within 15 days of screening ]
    Report positive predictive values of MRI

  4. Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI [ Time Frame: Within 15 days of screening ]
    Report negative predictive values of MRI


Secondary Outcome Measures :
  1. Infection Rate [ Time Frame: Up to 30 days post biopsy ]
    The infection rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of infection compared to standard transrectal biopsies .

  2. Hospitalization Rate [ Time Frame: Up to 30 days post biopsy ]
    The hospitalization rate within 30 days due to the procedure will be collected for expected acute events and these data will be used for reporting the study results for specific aim 2 evaluation the transperineal use of Uronav to determine if the transperineal biopsy approach results in a reduced rate of hospitalization compared to standard transrectal biopsies .

  3. Incidence of successful completion of transperineal biopsy procedure [ Time Frame: Up to 15 days after screening ]
    The study will be to report the incidence of successful completion of the transperineal biopsy procedure using the Uronav system which is provided by Philips Medical as part of the support for this study

  4. Dosimetric coverage of brachytherapy implant [ Time Frame: Up to 15 days after screening ]
    post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose

  5. Dosimetric coverage of targeted lesion [ Time Frame: Up to 15 days after screening ]
    post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histopathology confirmed prostate cancer that is Gleason score ≤7(4+3) clinical stage ≤ T2bN0M0 with a Prostate-specific antigen (PSA) below 15 ng/mL.
  • Patients must have MRI findings reporting intraprostatic lesions suspicious for malignancy.
  • Patient must not have had any prior treatment for prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
  • Subjects must have an International Prostate Symptom Score of ≤ 15.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Gleason score of ≥ 8(4+4)
  • PSA ≥ 15 ng/mL.
  • Clinical stage >T2b or evidence of nodal
  • Patients who are on anticoagulants or high dose aspirin therapy that cannot be safely stopped for greater than 10 days prior to treatment should be excluded to limit increased risk for urinary obstruction.
  • Patients with 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 compliance with study requirements.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the unlikely risk of prostate cancer being life threatening in this population.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681614


Contacts
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Contact: Bryan Traughber, MD 216-844-3100 bryan.traughber@uhhospitals.org

Locations
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United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Bryan Traughber, MD    216-844-3100    Bryan.Traughber@uhhospitals.org   
Principal Investigator: Bryan Traughber, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Bryan Traughber, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02681614     History of Changes
Other Study ID Numbers: CASE10814
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Case Comprehensive Cancer Center:
Imaging
Prostate
Multiparametric MRI
brachytherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases