Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02681614

Enrollment

Registered

2016-02-12

Start date

2016-07-21

Completion date

2018-02-11

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Imaging, Prostate, Multiparametric MRI, brachytherapy

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.

Interventions

DEVICEUronav 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.

DEVICEMagnetic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Had Biopsies With True Positives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of participants who had biopsies with true positives between biopsy tissue and intraprostatic MRI (sensitivity of the intraprostatic MRI)
Number of Biopsies With True Negatives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of biopsies with true negatives between biopsy tissue and intraprostatic MRI (specificity of the intraprostatic MRI)
Number of Biopsies With False Positives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of biopsies with false positives between biopsy tissue and intraprostatic MRI (positive predictive values of MRI)
Number of Biopsies With False Negatives Between Biopsy Tissue and Intraprostatic MRI	Within 15 days of screening	Number of biopsies with false negatives between biopsy tissue and intraprostatic MRI (negative predictive values of MRI)

Secondary

Measure	Time frame	Description
Dosimetric Coverage of Brachytherapy Implant Described by Mean D90 (% Rx)	Up to 15 days after screening	Dosimetric coverage of brachytherapy implant described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the post-implant prostate volume (given as a percent of the RX dose)
Number of Participants Who Had Successful Completion of Transperineal Biopsy Procedure	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
Dosimetric Coverage of Targeted Lesion Described by Mean D90 (%Rx)	Up to 15 days after screening	Dosimetric coverage of target lesion described by mean D90 (% Rx), which refers to the main dose in the hottest 90% of the targeted lesion volume (given as a percent of the RX dose)
Dosimetric Coverage of Targeted Lesion Described by Mean V100 (% Volume)	Up to 15 days after screening	post-operative radiation dose coverage reported as volumes of targeted lesion receiving a percentage of the prescribed dose, described by mean V100 (% Volume)
Number of Participants With Infections Within 30 Days	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 .
Number of Hospitalizations Within 30 Days	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 .
Dosimetric Coverage of Brachytherapy Implant Described by Mean V100 (% Volume)	Up to 15 days after screening	Post-operative radiation dose coverage reported as volumes of prostate receiving a percentage of the prescribed dose, described by mean V100 (% volume)

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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. 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.	5
Total	5

Arm

Count

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. 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. 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.

Total

Baseline characteristics

Characteristic	Uronav
Age, Customized 50-59 years	1 Participants
Age, Customized 60-69 years	2 Participants
Age, Customized 70-79 years	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	3 Participants
Region of Enrollment United States	5 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 5
other Total, other adverse events	5 / 5
serious Total, serious adverse events	1 / 5

Outcome results

Primary

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)

Time frame: Within 15 days of screening