Clinical trial NCT02681614: Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
Official title: Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Imaging
Prostate
Multiparametric MRI
brachytherapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI
timeFrame: Within 15 days of screening
measure: Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI
timeFrame: Within 15 days of screening
measure: Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI
timeFrame: Within 15 days of screening
measure: Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI
timeFrame: Within 15 days of screening
Secondary outcomes:
measure: Number of Participants With Infections Within 30 Days
timeFrame: Up to 30 days post biopsy
measure: Number of Hospitalizations Within 30 Days
timeFrame: Up to 30 days post biopsy
measure: Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure
timeFrame: Up to 15 days after screening
measure: Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)
timeFrame: Up to 15 days after screening
measure: Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)
timeFrame: Up to 15 days after screening
measure: Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)
timeFrame: Up to 15 days after screening
measure: Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)
timeFrame: Up to 15 days after screening
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Bryan Traughber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.