Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

NCT02681614 | Completed Results DMC FDA Device

• 1 other identifier: CASE10814
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Imaging; Prostate; Multiparametric MRI; brachytherapy

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI

  Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)

  Within 15 days of screening

• Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI

  Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)

  Within 15 days of screening

• Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI

  Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)

  Within 15 days of screening

• Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI

  Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)

  Within 15 days of screening

Secondary Outcomes (7)

• Number of Participants With Infections Within 30 Days

  Up to 30 days post biopsy

• Number of Hospitalizations Within 30 Days

  Up to 30 days post biopsy

• Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure

  Up to 15 days after screening

• Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)

  Up to 15 days after screening

• Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)

  Up to 15 days after screening

Study Arms (1)

Uronav

EXPERIMENTAL

Participants will undergo a Uronav guided biopsy with Magnetic Resonance Imaging confirmation. 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; Device: Magnetic resonance imaging

Interventions

Uronav guided biopsy DEVICE

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.

Also known as: Phillips Medical's Uronav

Uronav

Magnetic resonance imaging DEVICE

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.

Also known as: MRI

Uronav

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• Fredman E, Traughber B, Kharouta M, Podder T, Lo S, Ponsky L, MacLennan G, Paspulati R, Ellis B, Machtay M, Ellis R. Focal Prostate Stereotactic Body Radiation Therapy With Correlative Pathological and Radiographic-Based Treatment Planning. Front Oncol. 2021 Sep 15;11:744130. doi: 10.3389/fonc.2021.744130. eCollection 2021.

  PMID: 34604088 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Bryan Traughber
• Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

bryan.traughber@uhhospitals.org

+1 216-884-2516

Study Officials

• Bryan Traughber, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 12, 2016
• Study Start: July 21, 2016
• Primary Completion: January 25, 2018
• Study Completion: February 11, 2018
• Last Updated: June 30, 2022
• Results First Posted: July 14, 2020

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)